U.S. patent application number 16/580397 was filed with the patent office on 2020-01-16 for medical device systems and methods including helically configured or twisted, non-helically configured elongate members.
The applicant listed for this patent is KARDIUM INC.. Invention is credited to Calvin Dane CUMMINGS, John Andrew FUNK, Peter Josiah HAWES, Fernando Luis de Souza LOPES, Saar MOISA, Ashkan SARDARI, Derrick Kevin TO.
Application Number | 20200015890 16/580397 |
Document ID | / |
Family ID | 63792108 |
Filed Date | 2020-01-16 |
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United States Patent
Application |
20200015890 |
Kind Code |
A1 |
TO; Derrick Kevin ; et
al. |
January 16, 2020 |
MEDICAL DEVICE SYSTEMS AND METHODS INCLUDING HELICALLY CONFIGURED
OR TWISTED, NON-HELICALLY CONFIGURED ELONGATE MEMBERS
Abstract
A medical device system may include transducers and a structure
on which the transducers are located. The structure may include at
least a first portion of each elongate member of a plurality of
elongate members. Each respective set of a plurality of sets of one
or more of the transducers may be located on a respective one of
the plurality of elongate members. The structure may be selectively
moveable between a delivery configuration in which the structure is
sized to be percutaneously deliverable to a bodily cavity and a
deployed configuration in which the structure is sized too large to
be percutaneously deliverable to the bodily cavity. The second
portion of each elongate member of the plurality of elongate
members may be arranged in a helical configuration or a twisted,
non-helical configuration including at least 360 degrees of
rotation when the structure is in the delivery configuration.
Inventors: |
TO; Derrick Kevin;
(Vancouver, CA) ; LOPES; Fernando Luis de Souza;
(Delta, CA) ; MOISA; Saar; (Vancouver, CA)
; SARDARI; Ashkan; (North Vancouver, CA) ; FUNK;
John Andrew; (Delta, CA) ; HAWES; Peter Josiah;
(Burnaby, CA) ; CUMMINGS; Calvin Dane; (Surrey,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KARDIUM INC. |
Burnaby |
|
CA |
|
|
Family ID: |
63792108 |
Appl. No.: |
16/580397 |
Filed: |
September 24, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
PCT/CA2018/000072 |
Apr 9, 2018 |
|
|
|
16580397 |
|
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|
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62484456 |
Apr 12, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2018/00892
20130101; A61B 2018/00797 20130101; A61B 18/1492 20130101; A61B
2018/00577 20130101; A61B 2018/0016 20130101; A61B 2018/00827
20130101; A61B 2018/00214 20130101; A61B 2018/00267 20130101; A61B
2018/1435 20130101; A61B 2018/00351 20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14 |
Claims
1. A medical device system comprising: a plurality of transducer
sets, each transducer set comprising one or more transducers
positionable in a bodily cavity; and a plurality of elongate
members, at least parts of the elongate members collectively
forming a structure on which the plurality of transducer sets are
located, each elongate member comprising at least a particular
portion on which no transducer selectively operable to transmit
energy is located, wherein the structure is selectively moveable
between: a delivery configuration in which the structure is sized
to be percutaneously deliverable to the bodily cavity, each of the
particular portions of the plurality of elongate members comprising
a helical configuration including at least 360 degrees of rotation
when the structure is in the delivery configuration, and a deployed
configuration in which the structure is sized too large to be
percutaneously deliverable to the bodily cavity.
2. The medical device system of claim 1, wherein each transducer
set is located on at least one portion of a respective one of the
plurality of elongate members other than the particular portion of
the respective one of the plurality of elongate members.
3. The medical device system of claim 1, wherein the particular
portions of a set of at least two elongate members of the plurality
of elongate members are arranged in a collective helical
configuration when the structure is in the delivery
configuration.
4. The medical device system of claim 1, wherein the particular
portions of a set of at least two elongate members of the plurality
of elongate members are arranged in a collective helical
configuration when the structure is in the deployed
configuration.
5. The medical device system of claim 1, wherein the particular
portions of the plurality of elongate members are arranged in a
particular configuration that remains sufficiently small in size to
be percutaneously deliverable to the bodily cavity when the
structure is moved from the delivery configuration to the deployed
configuration.
6. The medical device system of claim 1, wherein the at least 360
degrees of rotation is at least 540 degrees of rotation.
7. The medical device system of claim 1, wherein the at least 360
degrees of rotation is at least 720 degrees of rotation.
8. The medical device system of claim 1, comprising a control
element coupled to at least one elongate member of the plurality of
elongate members to at least in part control a configuration of at
least the at least one elongate member, wherein the plurality of
elongate members wrap around at least a portion of the control
element at least when the structure is in the delivery
configuration.
9. The medical device system of claim 1, comprising a control
element coupled to at least one elongate member of the plurality of
elongate members to at least in part control a configuration of at
least the at least one elongate member, wherein the particular
portions of the plurality of elongate members wrap around at least
a portion of the control element at least when the structure is in
the delivery configuration.
10. The medical device system of claim 9, wherein the particular
portions of the plurality of elongate members wrap around at least
the portion of the control element when the structure is in the
deployed configuration.
11. The medical device system of claim 9, wherein the particular
portions of the plurality of elongate members each wraps around the
control element along a same rotational direction at least when the
structure is in the delivery configuration, the same rotational
direction being a same clockwise direction or a same
counterclockwise direction.
12. The medical device system of claim 1, wherein a portion of a
first elongate member of the plurality of elongate members is
nested with a portion of a second elongate member of the plurality
of elongate members at least when the structure is in the delivery
configuration.
13. The medical device system of claim 1, wherein the particular
portion of each of at least a first elongate member of the
plurality of elongate members is nested with the particular portion
of a second elongate member of the plurality of elongate members at
least when the structure is in the delivery configuration.
14. The medical device system of claim 1, wherein, for each
particular elongate member of the plurality of elongate members,
the particular portion of the particular elongate member and the
part of the particular elongate member that forms a respective part
of the structure are provided by a plurality of portions of the
particular elongate member arranged between a proximal portion of
the particular elongate member and a distal end of the particular
elongate member, the plurality of portions of the particular
elongate member collectively providing a front surface of the
particular elongate member and a back surface of the particular
elongate member opposite across a thickness of the particular
elongate member from the front surface of the particular elongate
member, wherein at least a portion of the front surface of each
particular elongate member of the plurality of elongate members
faces outwardly from an interior of the structure when the
structure is in the deployed configuration, and wherein at least a
contacting portion of the front surface of a first elongate member
of the plurality of elongate members contacts at least a contacting
portion of the back surface of a second elongate member of the
plurality of elongate members when the structure is in the delivery
configuration.
15. The medical device system of claim 14, wherein, for each
particular elongate member of the plurality of elongate members,
the particular elongate member comprises a flexible circuit
structure extending between the proximal portion of the particular
elongate member and the distal end of the particular elongate
member, the flexible circuit structure comprising the particular
portion of the particular elongate member.
16. The medical device system of claim 14, wherein at least the
contacting portion of the front surface of the first elongate
member follows a contour of at least the contacting portion of the
back surface of the second elongate member.
17. The medical device system of claim 16, wherein the contacting
portion of the front surface of the first elongate member is
provided by the particular portion of the first elongate member,
and the contacting portion of the back surface of the second
elongate member is provided by the particular portion of the second
elongate member.
18. The medical device system of claim 17, wherein at least the
contacting portion of the front surface of the first elongate
member follows the contour of at least the contacting portion of
the back surface of the second elongate member throughout the at
least 360 degrees of rotation of the helical configuration of the
particular portion of the second elongate member.
19. The medical device system of claim 1, wherein, for each
particular elongate member of the plurality of elongate members,
the particular portion of the particular elongate member and the
part of the particular elongate member that forms a respective part
of the structure are provided by a plurality of portions of the
particular elongate member arranged between a proximal portion of
the particular elongate member and a distal end of the particular
elongate member, the plurality of portions of the particular
elongate member collectively providing a front surface of the
particular elongate member and a back surface of the particular
elongate member opposite across a thickness of the particular
elongate member from the front surface of the particular elongate
member, wherein at least a portion of the front surface of each
elongate member of the plurality of elongate members faces
outwardly from an interior of the structure when the structure is
in the deployed configuration, and wherein at least the particular
portions of a first set of at least three of the plurality of
elongate members are arranged front surface-toward-back surface in
a first stacked arrangement when the structure is in the delivery
configuration.
20. The medical device system of claim 19, wherein at least the
particular portions of the first set of at least three of the
plurality of elongate members are arranged front
surface-toward-back surface in a second stacked arrangement when
the structure is in the deployed configuration.
21. The medical device system of claim 2, wherein each particular
elongate member of the plurality of elongate members comprises a
length between a proximal portion of the particular elongate member
and a distal end of the particular elongate member, wherein the
plurality of transducer sets are located on distal portions of the
plurality of elongate members, the distal portions closer, along
the lengths of the elongate members, to the distal ends of the
elongate members than the particular portions of the plurality of
elongate members when the structure is in the delivery
configuration.
22. The medical device system of claim 2, wherein the at least one
portions of the plurality of elongate members extend like lines of
longitude about the structure when the structure is in the deployed
configuration.
23. The medical device system of claim 2, wherein the at least one
portion of each elongate member of the plurality of elongate
members is not arranged in a helical configuration when the
structure is in the delivery configuration.
24. The medical device system of claim 2, wherein the at least one
portion of each elongate member of the plurality of elongate
members is not arranged in a helical configuration when the
structure is in the deployed configuration.
25. The medical device system of claim 3, wherein the particular
portions of the set of at least two elongate members of the
plurality of elongate members extend along a same rotational
direction in the collective helical configuration when the
structure is in the delivery configuration, the same rotational
direction being a same clockwise direction or a same
counterclockwise direction.
26. The medical device system of claim 1, wherein the helical
configuration of the particular portion of a first elongate member
of the plurality of elongate members is axially offset from the
helical configuration of the particular portion of at least a
second elongate member of the plurality of elongate members when
the structure is in the delivery configuration.
27. The medical device system of claim 26, wherein the particular
portion of the first elongate member of the plurality of elongate
members extends along a same rotational direction as the particular
portion of the second elongate member of the plurality of elongate
members when the structure is in the delivery configuration, the
same rotational direction being a same clockwise direction or a
same counterclockwise direction.
28. The medical device system of claim 1, comprising a shaft member
physically coupled to the plurality of elongate members, wherein a
location at which the shaft member is physically coupled to each
elongate member of the plurality of elongate members is fixed with
respect to a shaft distal end of the shaft member, the shaft member
configured to percutaneously deliver the structure to the bodily
cavity at least in response to translation of at least part of the
shaft member, and the shaft member comprising a shaft proximal end,
the shaft distal end, and an elongated portion extending between
the shaft proximal end and the shaft distal end, wherein the
particular portion of each elongate member of the plurality of
elongate member is located within the elongated portion of the
shaft member.
29. The medical device system of claim 1, wherein the plurality of
transducer sets includes a plurality of electrodes.
30. The medical device system of claim 1, wherein each transducer
of each transducer set of the plurality of transducer sets
comprises a respective electrode.
31. The medical device system of claim 1, wherein, for each
particular elongate member of the plurality of elongate members:
the particular portion of the particular elongate member is
between, along a length of the particular elongate member, (a) a
proximal portion of the particular elongate member and (b) the part
of the particular elongate member that forms a respective part of
the structure, and the part of the particular elongate member is
between the particular portion of the particular elongate member
and a distal end of the particular elongate member along the length
of the particular elongate member, the particular elongate member
configured to be percutaneously advanced distal end of the
particular elongate member ahead of at least the proximal portion
of the particular elongate member when the structure is in the
delivery configuration, and a first width of the particular
elongate member in the particular portion at least 10% less than a
corresponding second width of the particular elongate member in the
proximal portion of the particular elongate member.
32. The medical device system of claim 1, wherein, for each
particular elongate member of the plurality of elongate members:
the particular portion of the particular elongate member is
between, along a length of the particular elongate member, (a) a
proximal portion of the particular elongate member and (b) the part
of the particular elongate member that forms a respective part of
the structure, and the part of the particular elongate member is
between the particular portion of the particular elongate member
and a distal end of the particular elongate member along the length
of the particular elongate member, the particular elongate member
configured to be percutaneously advanced distal end of the
particular elongate member ahead of at least the proximal portion
of the particular elongate member when the structure is in the
delivery configuration, and a first width of the particular
elongate member in the particular portion is between 20% and 60%,
inclusive, less than a corresponding second width of the particular
elongate member in the proximal portion of the particular elongate
member.
33. The medical device system of claim 1, wherein, for each
particular elongate member of the plurality of elongate members:
the part of the particular elongate member, which forms a
respective part of the structure, and the particular portion of the
particular elongate member are provided by a plurality of portions
of the particular elongate member arranged between a proximal
portion of the particular elongate member and a distal end of the
particular elongate member, the plurality of portions of the
particular elongate member collectively providing a front surface
of the particular elongate member and a back surface of the
particular elongate member opposite across a thickness of the
particular elongate member from the front surface of the particular
elongate member, and the thickness of the particular elongate
member perpendicular to a longitudinal axis of the particular
elongate member.
34. The medical device system of claim 33, wherein, for each
particular elongate member of the plurality of elongate members: a
first width of the particular elongate member in the particular
portion of the particular elongate member is at least 10% less than
a second width of the particular elongate member in the proximal
portion of the particular elongate member, and each of the first
width and the second width is perpendicular to the thickness and
the longitudinal axis of the particular elongate member.
35. The medical device system of claim 33, wherein, for each
particular elongate member of the plurality of elongate members: a
first width of the particular elongate member in the particular
portion of the particular elongate member is between 20% and 60%,
inclusive, less than a second width of the particular elongate
member in the proximal portion of the particular elongate member,
and each of the first width and the second width is perpendicular
to the thickness and the longitudinal axis of the particular
elongate member.
36. The medical device system of claim 35, wherein the first widths
of the particular elongate members of the plurality of elongate
members are equal or within 5% of a same width.
37. The medical device system of claim 33, wherein, for each
particular elongate member of the plurality of elongate members:
the proximal portion of the particular elongate member is adjacent
the particular portion of the particular elongate member along the
longitudinal axis of the particular elongate member, and, in a
state where the longitudinal axis of the particular elongate member
resides within a same plane, the longitudinal axis of the
particular elongate member bends by a bending angle between the
proximal portion of the particular elongate member and the
particular portion of the particular elongate member, an absolute
value of the bending angle being at least 5 degrees.
38. The medical device system of claim 33, wherein, for each
particular elongate member of the plurality of elongate members:
the proximal portion of the particular elongate member is adjacent
the particular portion of the particular elongate member along the
longitudinal axis of the particular elongate member, and, in a
state where the longitudinal axis of the particular elongate member
resides within a same plane, the longitudinal axis of the
particular elongate member bends by a bending angle between the
proximal portion of the particular elongate member and the
particular portion of the particular elongate member, an absolute
value of the bending angle being between 10 and 20 degrees,
inclusive.
39. The medical device system of claim 38, wherein the bending
angle for each elongate member in a first subset of at least two
elongate members of the plurality of elongate members bends is
positive, and wherein the bending angle for each elongate member in
a second subset of at least two elongate members of the plurality
of elongate members bends is negative, the elongate members in the
first subset other than the elongate members in the second subset.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of International
Application No. PCT/CA2018/000072, filed Apr. 9, 2018, which claims
the benefit of U.S. Provisional Application No. 62/484,456, filed
Apr. 12, 2017, the entire disclosure of both of these applications
is hereby incorporated herein by reference.
TECHNICAL FIELD
[0002] Aspects of this disclosure generally are related at least to
medical systems including operative elongate members exhibiting
various configurations that facilitate delivery thereof to a bodily
cavity. Delivery of the operative elongate members may include
percutaneous or intravascular delivery thereof.
BACKGROUND
[0003] Cardiac surgery was initially undertaken using highly
invasive open procedures. A sternotomy, which is a type of incision
in the center of the chest that separates the sternum was typically
employed to allow access to the heart. In the past several decades,
more and more cardiac operations are performed using intravascular
or percutaneous techniques, where access to inner organs or other
tissue is gained via a catheter.
[0004] Intravascular or percutaneous surgeries benefit patients by
reducing surgery risk, complications and recovery time. However,
the use of intravascular or percutaneous technologies also raises
some particular challenges. Medical devices used in intravascular
or percutaneous surgery need to be deployed via catheter systems
which significantly increase the complexity of the device
structure. As well, doctors do not have direct visual contact with
the medical devices once the devices are positioned within the
body.
[0005] One example of where intravascular or percutaneous medical
techniques have been employed is in the treatment of a heart
disorder called atrial fibrillation. Atrial fibrillation is a
disorder in which spurious electrical signals cause an irregular
heartbeat. Atrial fibrillation has been treated with open heart
methods using a technique known as the "Cox-Maze procedure". During
this procedure, physicians create specific patterns of lesions in
the left and right atria to block various paths taken by the
spurious electrical signals. Such lesions were originally created
using incisions, but are now typically created by ablating the
tissue with various techniques including radio-frequency (RF)
energy, microwave energy, laser energy, electroporation and
cryogenic techniques. The procedure is performed with a high
success rate under the direct vision that is provided in open
procedures, but is relatively complex to perform intravascularly or
percutaneously because of the difficulty in creating the lesions in
the correct locations using catheter-based systems. Difficulties in
creating lesions in the correct locations within a bodily cavity
using intravascular or percutaneous techniques are often associated
with the delivery of various ablative elements to the bodily cavity
and the manipulation of the various ablative elements within the
bodily cavity. In this regard, the flexibility or the ability of
various carrier members to bend in various directions to accurately
deliver and position the ablative elements at the desired locations
is important.
[0006] In this regard, the present inventors recognized that there
exists a need in the art for improvement in various members
employed to deliver to and position transducers or other sensing or
ablative elements in one or more preferred locations within a
bodily cavity, such as a heart, in order to successfully perform
various diagnostic or treatment procedures.
SUMMARY
[0007] At least the above-discussed need is addressed and technical
solutions are achieved by various embodiments of the present
invention. In some embodiments, device systems and methods executed
by such systems exhibit enhanced capabilities for the delivery and
placement of one or more transducers provided by one or more
elongate members at various preferred locations with respect to
various regions of a tissue wall of a bodily cavity, and, in some
embodiments, formation of one or more lesions in at least one of
the various regions.
[0008] In some embodiments, a medical device system may be
summarized as including a plurality of transducers positionable in
a bodily cavity, and a structure on which the plurality of
transducers are located. The structure may include at least a first
portion of each elongate member of a plurality of elongate members.
The plurality of transducers may include a plurality of sets of one
or more of the transducers, each respective set of the plurality of
sets of one or more of the transducers located on a respective one
of the plurality of elongate members. The structure may be
selectively moveable between a delivery configuration in which the
structure is sized to be percutaneously deliverable to the bodily
cavity, and a deployed configuration in which the structure is
sized too large to be percutaneously deliverable to the bodily
cavity. In various embodiments, a second portion of each elongate
member of the plurality of elongate members is arranged in a
helical configuration including at least 360 degrees of rotation
when the structure is in the delivery configuration.
[0009] In some embodiments, the second portions of a set of at
least two elongate members of the plurality of elongate members may
be arranged in a collective helical configuration when the
structure is in the deployed configuration. In some embodiments,
the second portions of a set of at least two elongate members of
the plurality of elongate members may be arranged in a collective
helical configuration when the structure is in the delivery
configuration. In some embodiments, each particular elongate member
of the plurality of elongate members includes a length between a
proximal portion of the particular elongate member and a distal end
of the particular elongate member, and the plurality of sets of one
or more of the transducers is located on distal portions of the
plurality of elongate members, the distal portions closer, along
the lengths of the elongate members, to the distal ends of the
elongate members than the second portions of the plurality of
elongate members when the structure is in the delivery
configuration. In some embodiments, the second portions of the set
of at least two elongate members of the plurality of elongate
members may extend along a same rotational direction in the
collective helical configuration when the structure is in the
delivery configuration, the same rotational direction being a same
clockwise direction or a same counterclockwise direction.
[0010] In some embodiments, each respective set of the plurality of
sets of one or more of the transducers is located on the first
portion of a respective elongate member of the plurality of
elongate members. In some embodiments, the second portions of the
plurality of elongate members are arranged in a particular
configuration that remains sufficiently small in size to be
percutaneously deliverable to the bodily cavity when the structure
is moved from the delivery configuration to the deployed
configuration.
[0011] In some embodiments, each respective set of the plurality of
sets of one or more of the transducers is located on the first
portion of a respective elongate member of the plurality of
elongate members. In some embodiments, the first portions of the
plurality of elongate members are arranged in a configuration too
large to be percutaneously deliverable to the bodily cavity when
the structure is in the deployed configuration. In some
embodiments, the second portions of the plurality of elongate
members are arranged in a particular configuration that remains
sufficiently small in size to be percutaneously deliverable to the
bodily cavity when the structure is moved from the delivery
configuration to the deployed configuration.
[0012] In some embodiments, no transducer is located on the second
portion of each elongate member of the plurality of elongate
members.
[0013] In some embodiments, the at least 360 degrees of rotation is
at least 540 degrees of rotation. In some embodiments, the at least
360 degrees of rotation is at least 720 degrees of rotation.
[0014] In some embodiments, the medical device system may include a
control element coupled to at least one elongate member of the
plurality of elongate members to at least in part control a
configuration of at least the at least one elongate member, and the
plurality of elongate members may wrap around at least a portion of
the control element at least when the structure is in the delivery
configuration.
[0015] In some embodiments, the medical device system may include a
control element coupled to at least one elongate member of the
plurality of elongate members to at least in part control a
configuration thereof, and the second portions of the plurality of
elongate members may wrap around at least a portion of the control
element at least when the structure is in the delivery
configuration. In some embodiments, the second portions of the
plurality of elongate members may wrap around at least the portion
of the control element when the structure is in the deployed
configuration. In some embodiments, the second portions of the
plurality of elongate members each wraps around the control element
along a same rotational direction at least when the structure is in
the delivery configuration, the same rotational direction being a
same clockwise direction or a same counterclockwise direction.
[0016] In some embodiments, a portion of a first elongate member of
the plurality of elongate members may be nested with a portion of a
second elongate member of the plurality of elongate members at
least when the structure is in the delivery configuration. In some
embodiments, the second portion of each of at least a first
elongate member of the plurality of elongate members may be nested
with the second portion of a second elongate member of the
plurality of elongate members at least when the structure is in the
delivery configuration.
[0017] In some embodiments, for each particular elongate member of
the plurality of elongate members, the first portion of the
particular elongate member and the second portion of the particular
elongate member are provided by a plurality of portions of the
particular elongate member arranged between a proximal portion of
the particular elongate member and a distal end of the particular
elongate member, the plurality of portions of the particular
elongate member collectively providing a front surface of the
particular elongate member and a back surface of the particular
elongate member opposite across a thickness of the particular
elongate member from the front surface of the particular elongate
member. In some embodiments, at least a portion of the front
surface of each particular elongate member of the plurality of
elongate members faces outwardly from an interior of the structure
when the structure is in the deployed configuration, and at least a
particular portion of the front surface of a first elongate member
of the plurality of elongate members faces at least a particular
portion of the back surface of a second elongate member of the
plurality of elongate members when the structure is in the delivery
configuration. In some embodiments, at least the particular portion
of the front surface of the first elongate member may follow a
contour of at least the particular portion of the back surface of
the second elongate member. In some embodiments, the particular
portion of the front surface of the first elongate member may be
provided by the second portion of the first elongate member, and
the particular portion of the back surface of the second elongate
member may be provided by the second portion of the second elongate
member. In some embodiments, at least the particular portion of the
front surface of the first elongate member may follow the contour
of at least the particular portion of the back surface of the
second elongate member throughout the at least 360 degrees of
rotation of the helical configuration of the second portion of the
second elongate member.
[0018] In some embodiments, for each particular elongate member of
the plurality of elongate members, the first portion of the
particular elongate member and the second portion of the particular
elongate member are provided by a plurality of portions of the
particular elongate member arranged between a proximal portion of
the particular elongate member and a distal end of the particular
elongate member, the plurality of portions of the particular
elongate member collectively providing a front surface of the
particular elongate member and a back surface of the particular
elongate member opposite across a thickness of the particular
elongate member from the front surface of the particular elongate
member. In some embodiments, at least a portion of the front
surface of each elongate member of the plurality of elongate
members faces outwardly from an interior of the structure when the
structure is in the deployed configuration, and at least the second
portions of a first set of at least three of the plurality of
elongate members may be arranged front surface-toward-back surface
in a first stacked arrangement when the structure is in the
delivery configuration. In some embodiments, at least the second
portions of the first set of at least three of the plurality of
elongate members may be arranged front surface-toward-back surface
in a second stacked arrangement when the structure is in the
deployed configuration. In some embodiments, the first portions of
a second set of at least three of the plurality of elongate members
may be arranged front surface-toward-back surface in a second
stacked arrangement when the structure is in the delivery
configuration. In some embodiments, the second portions of a second
set of at least three of the plurality of elongate members may be
arranged front surface-toward-back surface in a second stacked
arrangement when the structure is in the delivery configuration. In
some embodiments, each respective set of the plurality of sets of
one or more of the transducers is located on the first portion of a
respective one of the elongate members. In some embodiments, the
second portions of the plurality of elongate members do not include
any transducers. In some embodiments, for each particular elongate
member of the plurality of elongate members, the particular
elongate member may include a flexible circuit structure extending
between the proximal portion of the particular elongate member and
the distal end of the particular elongate member, the flexible
circuit structure including the second portion of the particular
elongate member.
[0019] In some embodiments, the second portions of the plurality of
elongate members do not include any transducers. In some
embodiments, the second portions of the plurality of elongate
members do not include any electrodes.
[0020] In some embodiments, the first portions of the plurality of
elongate members may extend like lines of longitude about the
structure when the structure is in the deployed configuration. In
some embodiments, the first portion of each elongate member of the
plurality of elongate members is not arranged in a helical
configuration when the structure is in the delivery configuration.
In some embodiments, the first portion of each elongate member of
the plurality of elongate members is not arranged in a helical
configuration when the structure is in the deployed
configuration.
[0021] In some embodiments, the helical configuration of the second
portion of a first elongate member of the plurality of elongate
members may be axially offset from the helical configuration of the
second portion of at least a second elongate member of the
plurality of elongate members when the structure is in the delivery
configuration. In some embodiments, the second portion of the first
elongate member of the plurality of elongate members may extend
along a same rotational direction as the second portion of the
second elongate member of the plurality of elongate members when
the structure is in the delivery configuration, the same rotational
direction being a same clockwise direction or a same
counterclockwise direction.
[0022] In some embodiments, the medical device system may include a
shaft member physically coupled to the plurality of elongate
members, a location at which the shaft member is physically coupled
to each elongate member of the plurality of elongate members being
fixed with respect to a shaft distal end of the shaft member. The
shaft member may be configured to percutaneously deliver the
structure to the bodily cavity at least in response to translation
of at least part of the shaft member, and the shaft member may
include a shaft proximal end, the shaft distal end, and an
elongated portion extending between the shaft proximal end and the
shaft distal end. In some embodiments, the second portion of each
elongate member of the plurality of elongate member may be located
within the elongated portion of the shaft member.
[0023] In some embodiments, the plurality of transducers may
include a plurality of electrodes. In some embodiments, each
transducer of the plurality of transducers may include a respective
electrode.
[0024] In some embodiments, wherein, for each particular elongate
member of the plurality of elongate members: the second portion of
the particular elongate member is between a proximal portion of the
particular elongate member and the first portion of the particular
elongate member along a length of the particular elongate member,
and the first portion of the particular elongate member is between
the second portion of the particular elongate member and a distal
end of the particular elongate member along the length of the
particular elongate member. The particular elongate member may be
configured to be percutaneously advanced distal end of the
particular elongate member ahead of at least the proximal portion
of the particular elongate member when the structure is in the
delivery configuration. In some embodiments, a first width of the
particular elongate member in the second portion is at least 10%
less than a corresponding second width of the particular elongate
member in the proximal portion of the particular elongate member.
In some embodiments, the first width of the particular elongate
member in the second portion is between 20% and 60%, inclusive,
less than the corresponding second width of the particular elongate
member in the proximal portion of the particular elongate
member.
[0025] In some embodiments, wherein, for each particular elongate
member of the plurality of elongate members: the first portion of
the particular elongate member and the second portion of the
particular elongate member are provided by a plurality of portions
of the particular elongate member arranged between a proximal
portion of the particular elongate member and a distal end of the
particular elongate member. The plurality of portions of the
particular elongate member may collectively provide a front surface
of the particular elongate member and a back surface of the
particular elongate member opposite across a thickness of the
particular elongate member from the front surface of the particular
elongate member, and the thickness of the particular elongate
member may be perpendicular to a longitudinal axis of the
particular elongate member. In some embodiments, wherein, for each
particular elongate member of the plurality of elongate members: a
first width of the particular elongate member in the second portion
of the particular elongate member is at least 10% less, or in some
embodiments is between 20% and 60%, inclusive, less than a second
width of the particular elongate member in the proximal portion of
the particular elongate member, and each of the first width and the
second width is perpendicular to the thickness and the longitudinal
axis of the particular elongate member. In some embodiments, the
first widths of the particular elongate members of the plurality of
elongate members are equal or within 5% of a same width. In some
embodiments, wherein, for each particular elongate member of the
plurality of elongate members: the proximal portion of the
particular elongate member is adjacent the second portion of the
particular elongate member along the longitudinal axis of the
particular elongate member, and, in a state where the longitudinal
axis of the particular elongate member resides within a same plane,
the longitudinal axis of the particular elongate member bends by a
bending angle between the proximal portion of the particular
elongate member and the second portion of the particular elongate
member, an absolute value of the bending angle being at least 5
degrees, in some embodiments, and being between 10 and 20 degrees,
inclusive, in some embodiments. In some embodiments, the bending
angle for each elongate member in a first subset of at least two
elongate members of the plurality of elongate members is positive,
and the bending angle for each elongate member in a second subset
of at least two elongate members of the plurality of elongate
members is negative, the elongate members in the first subset other
than the elongate members in the second subset.
[0026] In some embodiments, various systems may include
combinations and subsets of the systems summarized above.
[0027] In some embodiments, a medical device system may be
summarized as including a plurality of transducer sets, each
transducer set including one or more transducers positionable in a
bodily cavity, and a plurality of elongate members, at least parts
of the elongate members collectively forming a structure on which
the plurality of transducer sets are located, each elongate member
including at least a particular portion on which no transducer
selectively operable to transmit energy is located. The structure
may be selectively moveable between a delivery configuration in
which the structure is sized to be percutaneously deliverable to
the bodily cavity and a deployed configuration in which the
structure is sized too large to be percutaneously deliverable to
the bodily cavity. In some embodiments, each of the particular
portions of the plurality of elongate members may include a helical
configuration including at least 360 degrees of rotation when the
structure is in the delivery configuration.
[0028] In some embodiments, each transducer set may be located on
at least one portion of a respective one of the plurality of
elongate members other than the particular portion of the
respective one of the plurality of elongate members. In some
embodiments, the particular portions of a set of at least two
elongate members of the plurality of elongate members may be
arranged in a collective helical configuration when the structure
is in the delivery configuration.
[0029] In some embodiments, the particular portions of a set of at
least two elongate members of the plurality of elongate members may
be arranged in a collective helical configuration when the
structure is in the deployed configuration.
[0030] In some embodiments, the particular portions of the
plurality of elongate members may be arranged in a particular
configuration that remains sufficiently small in size to be
percutaneously deliverable to the bodily cavity when the structure
is moved from the delivery configuration to the deployed
configuration.
[0031] In some embodiments, the at least 360 degrees of rotation is
at least 540 degrees of rotation. In some embodiments, the at least
360 degrees of rotation is at least 720 degrees of rotation.
[0032] In some embodiments, the medical device system may include a
control element coupled to at least one elongate member of the
plurality of elongate members to at least in part control a
configuration of at least the at least one elongate member and the
plurality of elongate members may wrap around at least a portion of
the control element at least when the structure is in the delivery
configuration.
[0033] In some embodiments, the medical device system may include a
control element coupled to at least one elongate member of the
plurality of elongate members to at least in part control a
configuration of at least the at least one elongate member, and the
particular portions of the plurality of elongate members may wrap
around at least a portion of the control element at least when the
structure is in the delivery configuration. In some embodiments,
the particular portions of the plurality of elongate members may
wrap around at least the portion of the control element when the
structure is in the deployed configuration. In some embodiments the
particular portions of the plurality of elongate members each may
wrap around the control element along a same rotational direction
at least when the structure is in the delivery configuration, the
same rotational direction being a same clockwise direction or a
same counterclockwise direction.
[0034] In some embodiments, a portion of a first elongate member of
the plurality of elongate members may be nested with a portion of a
second elongate member of the plurality of elongate members at
least when the structure is in the delivery configuration. In some
embodiments, the particular portion of each of at least a first
elongate member of the plurality of elongate members may be nested
with the particular portion of a second elongate member of the
plurality of elongate members at least when the structure is in the
delivery configuration.
[0035] In some embodiments, for each particular elongate member of
the plurality of elongate members, the particular portion of the
particular elongate member and the part of the particular elongate
member that forms a respective part of the structure are provided
by a plurality of portions of the particular elongate member
arranged between a proximal portion of the particular elongate
member and a distal end of the particular elongate member, the
plurality of portions of the particular elongate member
collectively providing a front surface of the particular elongate
member and a back surface of the particular elongate member
opposite across a thickness of the particular elongate member from
the front surface of the particular elongate member. In some
embodiments, at least a portion of the front surface of each
particular elongate member of the plurality of elongate members
faces outwardly from an interior of the structure when the
structure is in the deployed configuration, and at least a
contacting portion of the front surface of a first elongate member
of the plurality of elongate members contacts at least a contacting
portion of the back surface of a second elongate member of the
plurality of elongate members when the structure is in the delivery
configuration. In some embodiments, for each particular elongate
member of the plurality of elongate members, the particular
elongate member may include a flexible circuit structure extending
between the proximal portion of the particular elongate member and
the distal end of the particular elongate member, the flexible
circuit structure including the particular portion of the
particular elongate member. In some embodiments, at least the
contacting portion of the front surface of the first elongate
member may follow a contour of at least the contacting portion of
the back surface of the second elongate member. In some
embodiments, the contacting portion of the front surface of the
first elongate member may be provided by the particular portion of
the first elongate member, and the contacting portion of the back
surface of the second elongate member may be provided by the
particular portion of the second elongate member. In some
embodiments, at least the contacting portion of the front surface
of the first elongate member may follow the contour of at least the
contacting portion of the back surface of the second elongate
member throughout the at least 360 degrees of rotation of the
helical configuration of the particular portion of the second
elongate member.
[0036] In some embodiments, for each particular elongate member of
the plurality of elongate members, the particular portion of the
particular elongate member and the part of the particular elongate
member that forms a respective part of the structure may be
provided by a plurality of portions of the particular elongate
member arranged between a proximal portion of the particular
elongate member and a distal end of the particular elongate member,
the plurality of portions of the particular elongate member
collectively providing a front surface of the particular elongate
member and a back surface of the particular elongate member
opposite across a thickness of the particular elongate member from
the front surface of the particular elongate member. In some
embodiments, at least a portion of the front surface of each
elongate member of the plurality of elongate members faces
outwardly from an interior of the structure when the structure is
in the deployed configuration, and at least the particular portions
of a first set of at least three of the plurality of elongate
members are arranged front surface-toward-back surface in a first
stacked arrangement when the structure is in the delivery
configuration. In some embodiments, at least the particular
portions of the first set of at least three of the plurality of
elongate members may be arranged front surface-toward-back surface
in a second stacked arrangement when the structure is in the
deployed configuration.
[0037] In some embodiments, each transducer set may be located on
at least one portion of a respective one of the plurality of
elongate members other than the particular portion of the
respective one of the plurality of elongate members. In some
embodiments, each particular elongate member of the plurality of
elongate members includes a length between a proximal portion of
the particular elongate member and a distal end of the particular
elongate member, and the plurality of transducer sets may be
located on distal portions of the plurality of elongate members,
the distal portions closer, along the lengths of the elongate
members, to the distal ends of the elongate members than the
particular portions of the plurality of elongate members when the
structure is in the delivery configuration. In some embodiments,
the at least one portions of the plurality of elongate members may
extend like lines of longitude about the structure when the
structure is in the deployed configuration. In some embodiments,
the at least one portion of each elongate member of the plurality
of elongate members is not arranged in a helical configuration when
the structure is in the delivery configuration. In some
embodiments, the at least one portion of each elongate member of
the plurality of elongate members is not arranged in a helical
configuration when the structure is in the deployed
configuration.
[0038] In some embodiments, the particular portions of a set of at
least two elongate members of the plurality of elongate members may
be arranged in a collective helical configuration when the
structure is in the deployed configuration. In some embodiments,
the particular portions of the set of at least two elongate members
of the plurality of elongate members may extend along a same
rotational direction in the collective helical configuration when
the structure is in the delivery configuration, the same rotational
direction being a same clockwise direction or a same
counterclockwise direction.
[0039] In some embodiments, the helical configuration of the
particular portion of a first elongate member of the plurality of
elongate members may be axially offset from the helical
configuration of the particular portion of at least a second
elongate member of the plurality of elongate members when the
structure is in the delivery configuration. In some embodiments,
the particular portion of the first elongate member of the
plurality of elongate members may extend along a same rotational
direction as the particular portion of the second elongate member
of the plurality of elongate members when the structure is in the
delivery configuration, the same rotational direction being a same
clockwise direction or a same counterclockwise direction.
[0040] In some embodiments, the medical device system may include a
shaft member physically coupled to the plurality of elongate
members, and a location at which the shaft member is physically
coupled to each elongate member of the plurality of elongate
members is fixed with respect to a shaft distal end of the shaft
member. In some embodiments, the shaft member is configured to
percutaneously deliver the structure to the bodily cavity at least
in response to translation of at least part of the shaft member. In
some embodiments, the shaft member includes a shaft proximal end,
the shaft distal end, and an elongated portion extending between
the shaft proximal end and the shaft distal end, and the particular
portion of each elongate member of the plurality of elongate member
is located within the elongated portion of the shaft member.
[0041] In some embodiments, the plurality of transducer sets may
include a plurality of electrodes. In some embodiments, each
transducer of each transducer set of the plurality of transducer
sets may include a respective electrode.
[0042] In some embodiments, for each particular elongate member of
the plurality of elongate members: the particular portion of the
particular elongate member is between, along a length of the
particular elongate member, (a) a proximal portion of the
particular elongate member and (b) the part of the particular
elongate member that forms a respective part of the structure, and
the part of the particular elongate member is between the
particular portion of the particular elongate member and a distal
end of the particular elongate member along the length of the
particular elongate member. The particular elongate member may be
configured to be percutaneously advanced distal end of the
particular elongate member ahead of at least the proximal portion
of the particular elongate member when the structure is in the
delivery configuration. A first width of the particular elongate
member in the particular portion may be at least 10% less, or in
some embodiments is between 20% and 60%, inclusive, less than a
corresponding second width of the particular elongate member in the
proximal portion of the particular elongate member.
[0043] In some embodiments, for each particular elongate member of
the plurality of elongate members: the part of the particular
elongate member, which forms a respective part of the structure,
and the particular portion of the particular elongate member are
provided by a plurality of portions of the particular elongate
member arranged between a proximal portion of the particular
elongate member and a distal end of the particular elongate member.
The plurality of portions of the particular elongate member may
collectively provide a front surface of the particular elongate
member and a back surface of the particular elongate member
opposite across a thickness of the particular elongate member from
the front surface of the particular elongate member. The thickness
of the particular elongate member may be perpendicular to a
longitudinal axis of the particular elongate member. In some
embodiments, for each particular elongate member of the plurality
of elongate members: a first width of the particular elongate
member in the particular portion of the particular elongate member
is at least 10% less, or in some embodiments is between 20% and
60%, inclusive, less than a second width of the particular elongate
member in the proximal portion of the particular elongate member.
In some embodiments, each of the first width and the second width
is perpendicular to the thickness and the longitudinal axis of the
particular elongate member. In some embodiments, the first widths
of the particular elongate members of the plurality of elongate
members are equal or within 5% of a same width.
[0044] In some embodiments, for each particular elongate member of
the plurality of elongate members: the proximal portion of the
particular elongate member is adjacent the particular portion of
the particular elongate member along the longitudinal axis of the
particular elongate member, and, in a state where the longitudinal
axis of the particular elongate member resides within a same plane.
In some embodiments, the longitudinal axis of the particular
elongate member bends by a bending angle between the proximal
portion of the particular elongate member and the particular
portion of the particular elongate member. An absolute value of the
bending angle may be at least 5 degrees in some embodiments, or may
be between 10 and 20 degrees, inclusive in some embodiments. In
some embodiments, the bending angle for each elongate member in a
first subset of at least two elongate members of the plurality of
elongate members bends is positive, and the bending angle for each
elongate member in a second subset of at least two elongate members
of the plurality of elongate members bends is negative, in some
embodiments, the elongate members in the first subset other than
the elongate members in the second subset.
[0045] In some embodiments, various systems may include
combinations and subsets of the systems summarized above.
[0046] In some embodiments, a medical device system may be
summarized as including a plurality of transducer sets, each
transducer set including one or more transducers positionable in a
bodily cavity. The medical device system may include a plurality of
elongate members, at least parts of the elongate members
collectively forming a structure on which the plurality of
transducers are located, each elongate member including at least a
first portion on which a respective transducer set of the plurality
of transducer sets of the transducers is located. The medical
device system may include a shaft member physically coupled to the
plurality of elongate members. In some embodiments, a location at
which the shaft member is physically coupled to each elongate
member of the plurality of elongate members is fixed with respect
to a shaft distal end of the shaft member to deliver the structure
through a bodily opening leading to a bodily cavity at least in
response to translation of at least part of the shaft member. In
some embodiments, the shaft member includes a shaft proximal end,
the shaft distal end, and an elongated portion extending between
the shaft proximal end and the shaft distal end. In some
embodiments, each of the first portions of the plurality of
elongate members may extend outwardly from the shaft distal end of
the shaft member, and each elongate member may include a second
portion located within the elongated portion of the shaft member,
each second portion including a helical configuration.
[0047] In some embodiments, each second portion may include a
helical configuration including at least 360 degrees of rotation.
In some embodiments, each second portion may include a helical
configuration including at least 540 degrees of rotation. In some
embodiments, each second portion may include a helical
configuration including at least 720 degrees of rotation.
[0048] In some embodiments, the structure may be selectively
moveable between a delivery configuration in which the structure is
sized to be percutaneously deliverable to the bodily cavity, and a
deployed configuration in which the structure is sized too large to
be percutaneously deliverable to the bodily cavity. In some
embodiments, the second portions of a set of at least two elongate
members of the plurality of elongate members may be arranged in a
collective helical configuration when the structure is in the
delivery configuration. In some embodiments, the second portions of
a set of at least two elongate members of the plurality of elongate
members may be arranged in a collective helical configuration when
the structure is in the deployed configuration. In some
embodiments, the first portions of the plurality of elongate
members may be arranged in a configuration too large to be
percutaneously deliverable to the bodily cavity when the structure
is in the deployed configuration.
[0049] In some embodiments, no transducer is located on the second
portion of each elongate member of the plurality of elongate
members.
[0050] In some embodiments, the structure may be selectively
moveable between a delivery configuration in which the structure is
sized to be percutaneously deliverable to the bodily cavity, and a
deployed configuration in which the structure is sized too large to
be percutaneously deliverable to the bodily cavity. In some
embodiments, the medical device system may include a control
element coupled to at least one elongate member of the plurality of
elongate members to at least in part control a configuration of at
least the at least one elongate member. In some embodiments, the
plurality of elongate members may wrap around at least a portion of
the control element at least when the structure is in the delivery
configuration.
[0051] In some embodiments, the structure may be selectively
moveable between a delivery configuration in which the structure is
sized to be percutaneously deliverable to the bodily cavity, and a
deployed configuration in which the structure is sized too large to
be percutaneously deliverable to the bodily cavity. In some
embodiments, the medical device system may include a control
element coupled to at least one elongate member of the plurality of
elongate members to at least in part control a configuration of at
least the at least one elongate member. In some embodiments, the
second portions of the plurality of elongate members may wrap
around at least a portion of the control element at least when the
structure is in the delivery configuration. In some embodiments,
the second portions of the plurality of elongate members may wrap
around at least the portion of the control element when the
structure is in the deployed configuration. In some embodiments,
the second portions of the plurality of elongate members each may
wrap around the control element along a same rotational direction
at least when the structure is in the delivery configuration, the
same rotational direction being a same clockwise direction or a
same counterclockwise direction.
[0052] In some embodiments, the structure may be selectively
moveable between a delivery configuration in which the structure is
sized to be percutaneously deliverable to the bodily cavity, and a
deployed configuration in which the structure is sized too large to
be percutaneously deliverable to the bodily cavity. In some
embodiments, the second portion of each of at least a first
elongate member of the plurality of elongate members may be nested
with the second portion of a second elongate member of the
plurality of elongate members at least when the structure is in the
delivery configuration.
[0053] In some embodiments, the structure may be selectively
moveable between a delivery configuration in which the structure is
sized to be percutaneously deliverable to the bodily cavity, and a
deployed configuration in which the structure is sized too large to
be percutaneously deliverable to the bodily cavity. In some
embodiments, for each particular elongate member of the plurality
of elongate members, the first portion of the particular elongate
member and the second portion of the particular elongate member may
be provided by a plurality of portions of the particular elongate
member arranged between a proximal portion of the particular
elongate member and a distal end of the particular elongate member,
the plurality of portions of the particular elongate member
collectively providing a front surface of the particular elongate
member and a back surface of the particular elongate member
opposite across a thickness of the particular elongate member from
the front surface of the particular elongate member. In some
embodiments, at least a portion of the front surface of each
particular elongate member of the plurality of elongate members may
face outwardly from an interior of the structure when the structure
is in the deployed configuration, and at least a particular portion
of the front surface of a first elongate member of the plurality of
elongate members may face at least a particular portion of the back
surface of a second elongate member of the plurality of elongate
members when the structure is in the delivery configuration. In
some embodiments, for each particular elongate member of the
plurality of elongate members, the particular elongate member may
include a flexible circuit structure extending between the proximal
portion of the particular elongate member and the distal end of the
particular elongate member, the flexible circuit structure
including the second portion of the particular elongate member. In
some embodiments, at least the particular portion of the front
surface of the first elongate member may follow a contour of at
least the particular portion of the back surface of the second
elongate member at least when the structure is in the delivery
configuration. In some embodiments, the particular portion of the
front surface of the first elongate member may be provided by the
second portion of the first elongate member, and the particular
portion of the back surface of the second elongate member may be
provided by the second portion of the second elongate member. In
some embodiments, at least the particular portion of the front
surface of the first elongate member may follow the contour of at
least the particular portion of the back surface of the second
elongate member throughout a helical rotation of the helical
configuration of the second portion of the second elongate
member.
[0054] In some embodiments, the structure may be selectively
moveable between a delivery configuration in which the structure is
sized to be percutaneously deliverable to the bodily cavity, and a
deployed configuration in which the structure is sized too large to
be percutaneously deliverable to the bodily cavity. In some
embodiments, for each particular elongate member of the plurality
of elongate members, the first portion of the particular elongate
member and the second portion of the particular elongate member may
be provided by a plurality of portions of the particular elongate
member arranged between a proximal portion of the particular
elongate member and a distal end of the particular elongate member,
the plurality of portions of the particular elongate member
collectively providing a front surface of the particular elongate
member and a back surface of the particular elongate member
opposite across a thickness of the particular elongate member from
the front surface of the particular elongate member. In some
embodiments at least a portion of the front surface of each
elongate member of the plurality of elongate members may face
outwardly from an interior of the structure when the structure is
in the deployed configuration, and at least the second portions of
a first set of at least three of the plurality of elongate members
may be arranged front surface-toward-back surface in a first
stacked arrangement when the structure is in the delivery
configuration. In some embodiments, at least the second portions of
the first set of at least three of the plurality of elongate
members may be arranged front surface-toward-back surface in a
second stacked arrangement when the structure is in the deployed
configuration. In some embodiments, the first portions of a second
set of at least three of the plurality of elongate members may be
arranged front surface-toward-back surface in a second stacked
arrangement when the structure is in the delivery configuration. In
some embodiments, the second portions of a second set of at least
three of the plurality of elongate members may be arranged front
surface-toward-back surface in a second stacked arrangement when
the structure is in the delivery configuration.
[0055] In some embodiments, the structure may be selectively
moveable between a delivery configuration in which the structure is
sized to be percutaneously deliverable to the bodily cavity, and a
deployed configuration in which the structure is sized too large to
be percutaneously deliverable to the bodily cavity. In some
embodiments, the first portions of the plurality of elongate
members may extend like lines of longitude about the structure when
the structure is in the deployed configuration. In some
embodiments, the first portion of each elongate member of the
plurality of elongate members is not arranged in a helical
configuration when the structure is in the delivery
configuration.
[0056] In some embodiments, the structure may be selectively
moveable between a delivery configuration in which the structure is
sized to be percutaneously deliverable to the bodily cavity, and a
deployed configuration in which the structure is sized too large to
be percutaneously deliverable to the bodily cavity. In some
embodiments, the second portions of a set of at least two elongate
members of the plurality of elongate members are arranged in a
collective helical configuration when the structure is in the
delivery configuration. In some embodiments, the first portion of
each elongate member of the plurality of elongate members is not
arranged in a helical configuration when the structure is in the
deployed configuration. In some embodiments, the second portions of
the set of at least two elongate members of the plurality of
elongate members may extend along a same rotational direction in
the collective helical configuration when the structure is in the
delivery configuration, the same rotational direction being a same
clockwise direction or a same counterclockwise direction.
[0057] In some embodiments, the structure may be selectively
moveable between a delivery configuration in which the structure is
sized to be percutaneously deliverable to the bodily cavity, and a
deployed configuration in which the structure is sized too large to
be percutaneously deliverable to the bodily cavity. In some
embodiments, the helical configuration of the second portion of a
first elongate member of the plurality of elongate members may be
axially offset from the helical configuration of the second portion
of at least a second elongate member of the plurality of elongate
members when the structure is in the delivery configuration. In
some embodiments, the second portion of the first elongate member
of the plurality of elongate members may extend along a same
rotational direction as the second portion of the second elongate
member of the plurality of elongate members when the structure is
in the delivery configuration, the same rotational direction being
a same clockwise direction or a same counterclockwise
direction.
[0058] In some embodiments, the plurality of transducers may
include a plurality of electrodes. In some embodiments, each
transducer of the plurality of transducers may include a respective
electrode.
[0059] In some embodiments, wherein, for each particular elongate
member of the plurality of elongate members: the second portion of
the particular elongate member is between a proximal portion of the
particular elongate member and the first portion of the particular
elongate member along a length of the particular elongate member,
and the first portion of the particular elongate member is between
the second portion of the particular elongate member and a distal
end of the particular elongate member along the length of the
particular elongate member. The particular elongate member may be
configured to be percutaneously advanced distal end of the
particular elongate member ahead of at least the proximal portion
of the particular elongate member when the structure is in the
delivery configuration. In some embodiments, a first width of the
particular elongate member in the second portion is at least 10%
less than a corresponding second width of the particular elongate
member in the proximal portion of the particular elongate member.
In some embodiments, the first width of the particular elongate
member in the second portion is between 20% and 60%, inclusive,
less than the corresponding second width of the particular elongate
member in the proximal portion of the particular elongate
member.
[0060] In some embodiments, wherein, for each particular elongate
member of the plurality of elongate members: the first portion of
the particular elongate member and the second portion of the
particular elongate member are provided by a plurality of portions
of the particular elongate member arranged between a proximal
portion of the particular elongate member and a distal end of the
particular elongate member. The plurality of portions of the
particular elongate member may collectively provide a front surface
of the particular elongate member and a back surface of the
particular elongate member opposite across a thickness of the
particular elongate member from the front surface of the particular
elongate member, and the thickness of the particular elongate
member may be perpendicular to a longitudinal axis of the
particular elongate member. In some embodiments, wherein, for each
particular elongate member of the plurality of elongate members: a
first width of the particular elongate member in the second portion
of the particular elongate member is at least 10% less, or in some
embodiments is between 20% and 60%, inclusive, less than a second
width of the particular elongate member in the proximal portion of
the particular elongate member, and each of the first width and the
second width is perpendicular to the thickness and the longitudinal
axis of the particular elongate member. In some embodiments, the
first widths of the particular elongate members of the plurality of
elongate members are equal or within 5% of a same width. In some
embodiments, wherein, for each particular elongate member of the
plurality of elongate members: the proximal portion of the
particular elongate member is adjacent the second portion of the
particular elongate member along the longitudinal axis of the
particular elongate member, and, in a state where the longitudinal
axis of the particular elongate member resides within a same plane,
the longitudinal axis of the particular elongate member bends by a
bending angle between the proximal portion of the particular
elongate member and the second portion of the particular elongate
member, an absolute value of the bending angle being at least 5
degrees, in some embodiments, and being between 10 and 20 degrees,
inclusive, in some embodiments. In some embodiments, the bending
angle for each elongate member in a first subset of at least two
elongate members of the plurality of elongate members is positive,
and the bending angle for each elongate member in a second subset
of at least two elongate members of the plurality of elongate
members is negative, the elongate members in the first subset other
than the elongate members in the second subset.
[0061] In some embodiments, various systems may include
combinations and subsets of the systems summarized above.
[0062] In some embodiments, a medical device system may be
summarized as including a plurality of transducer sets, each
transducer set including one or more transducers positionable in a
bodily cavity; a plurality of elongate members, at least parts of
the elongate members collectively forming a structure on which the
plurality of transducers are located, each elongate member
comprising at least a first portion on which a respective
transducer set of the plurality of transducer sets of the
transducers is located, and a shaft member physically coupled to
the plurality of elongate members, a location at which the shaft
member is physically coupled to each elongate member of the
plurality of elongate members is fixed with respect to a shaft
distal end of the shaft member to deliver the structure through a
bodily opening leading to a bodily cavity at least in response to
translation of at least part of the shaft member, the shaft member
including a shaft proximal end, the shaft distal end, and an
elongated portion extending between the shaft proximal end and the
shaft distal end, wherein each of the first portions of the
plurality of elongate members extends outwardly from the shaft
distal end of the shaft member, and wherein each elongate member
comprises a second portion located within the elongated portion of
the shaft member, each second portion comprising a twisted,
non-helical configuration including at least 360 degrees of
rotation.
[0063] In some embodiments, each second portion includes a twisted,
non-helical configuration including at least 540 degrees of
rotation. In some embodiments, each second portion includes a
twisted, non-helical configuration including at least 720 degrees
of rotation.
[0064] In some embodiments, the shaft member includes a shaft
proximal end, the shaft distal end, and a longitudinal axis
extending between the shaft proximal end and the shaft distal end.
Each second portion may be intersected by the longitudinal
axis.
[0065] In some embodiments, no transducer is located on the second
portion of each elongate member of the plurality of elongate
members.
[0066] In some embodiments, the plurality of transducers includes a
plurality of electrodes.
[0067] In some embodiments, each of the plurality of transducers
comprises a respective electrode.
[0068] In some embodiments, the structure is selectively moveable
between: a delivery configuration in which the structure is sized
to be percutaneously deliverable to the bodily cavity, and a
deployed configuration in which the structure is sized too large to
be percutaneously deliverable to the bodily cavity.
[0069] In some embodiments, the second portions of a set of at
least two elongate members of the plurality of elongate members are
arranged in a collective twisted, non-helical configuration when
the structure is in the delivery configuration. The second portions
of the set of at least two elongate members of the plurality of
elongate members may extend along a same rotational direction in
the collective twisted, non-helical configuration when the
structure is in the delivery configuration, the same rotational
direction being a same clockwise direction or a same
counterclockwise direction in some embodiments.
[0070] In some embodiments, the second portions of a set of at
least two elongate members of the plurality of elongate members are
arranged in a collective twisted, non-helical configuration when
the structure is in the deployed configuration.
[0071] In some embodiments, the first portions of the plurality of
elongate members are arranged in a configuration too large to be
percutaneously deliverable to the bodily cavity when the structure
is in the deployed configuration.
[0072] In some embodiments, the second portion of each of at least
a first elongate member of the plurality of elongate members is
nested with the second portion of a second elongate member of the
plurality of elongate members at least when the structure is in the
delivery configuration.
[0073] In some embodiments, wherein, for each particular elongate
member of the plurality of elongate members, the first portion of
the particular elongate member and the second portion of the
particular elongate member are provided by a plurality of portions
of the particular elongate member arranged between a proximal
portion of the particular elongate member and a distal end of the
particular elongate member, the plurality of portions of the
particular elongate member collectively providing a front surface
of the particular elongate member and a back surface of the
particular elongate member opposite across a thickness of the
particular elongate member from the front surface of the particular
elongate member. At least a portion of the front surface of each
particular elongate member of the plurality of elongate members may
face outwardly from an interior of the structure when the structure
is in the deployed configuration, and at least a particular portion
of the front surface of a first elongate member of the plurality of
elongate members may face at least a particular portion of the back
surface of a second elongate member of the plurality of elongate
members when the structure is in the delivery configuration. In
some embodiments, wherein, for each particular elongate member of
the plurality of elongate members, the particular elongate member
includes a flexible circuit structure extending between the
proximal portion of the particular elongate member and the distal
end of the particular elongate member, the flexible circuit
structure including the second portion of the particular elongate
member. In some embodiments, at least the particular portion of the
front surface of the first elongate member follows a contour of at
least the particular portion of the back surface of the second
elongate member at least when the structure is in the delivery
configuration. In some embodiments, the particular portion of the
front surface of the first elongate member is provided by the
second portion of the first elongate member, and the particular
portion of the back surface of the second elongate member is
provided by the second portion of the second elongate member. In
some embodiments, at least the particular portion of the front
surface of the first elongate member follows the contour of at
least the particular portion of the back surface of the second
elongate member throughout a rotation of the twisted, non-helical
configuration of the second portion of the second elongate
member.
[0074] In some embodiments, wherein, for each particular elongate
member of the plurality of elongate members, the first portion of
the particular elongate member and the second portion of the
particular elongate member are provided by a plurality of portions
of the particular elongate member arranged between a proximal
portion of the particular elongate member and a distal end of the
particular elongate member, the plurality of portions of the
particular elongate member collectively providing a front surface
of the particular elongate member and a back surface of the
particular elongate member opposite across a thickness of the
particular elongate member from the front surface of the particular
elongate member. At least a portion of the front surface of each
elongate member of the plurality of elongate members may face
outwardly from an interior of the structure when the structure is
in the deployed configuration, and at least the second portions of
a first set of at least three of the plurality of elongate members
may be arranged front surface-toward-back surface in a first
stacked arrangement when the structure is in the delivery
configuration. In some embodiments, at least the second portions of
the first set of at least three of the plurality of elongate
members are arranged front surface-toward-back surface in a second
stacked arrangement when the structure is in the deployed
configuration. In some embodiments, the first portions of the first
set of at least three of the plurality of elongate members are
arranged front surface-toward-back surface in a second stacked
arrangement when the structure is in the delivery
configuration.
[0075] In some embodiments, the first portions of the plurality of
elongate members extend like lines of longitude about the structure
when the structure is in the deployed configuration.
[0076] In some embodiments, the first portion of each elongate
member of the plurality of elongate members is not arranged in a
twisted, non-helical configuration including at least 360 degrees
of rotation when the structure is in the delivery
configuration.
[0077] In some embodiments, various systems may include
combinations and subsets of the systems summarized above.
[0078] Various embodiments of the present invention may include
systems, devices, or machines that are or include combinations or
subsets of any one or more of the systems, devices, or machines and
associated features thereof described herein.
[0079] Further, all or part of any one or more of the systems,
devices, or machines discussed herein or combinations or
sub-combinations thereof may implement or execute all or part of
any one or more of the processes or methods discussed herein or
combinations or sub-combinations thereof.
[0080] Any of the features of all or part of any one or more of the
methods or processes discussed herein may be combined with any of
the other features of all or part of any one or more of the methods
and processes discussed herein. In addition, a computer program
product may be provided that comprises program code portions for
performing some or all of any one or more of the methods or
processes and associated features thereof described herein, when
the computer program product is executed by a computer or other
computing device or device system. Such a computer program product
may be stored on one or more computer-readable storage mediums,
also referred to as one or more computer-readable data storage
mediums.
[0081] In some embodiments, each of any of one or more of the
computer-readable data storage medium systems (also referred to as
processor-accessible memory device systems) described herein is a
non-transitory computer-readable (or processor-accessible) data
storage medium system (or memory device system) including or
consisting of one or more non-transitory computer-readable (or
processor-accessible) storage mediums (or memory devices) storing
the respective program(s) which may configure a data processing
device system to execute some or all of any of one or more of the
methods or processes described herein.
[0082] Further, any of one or more of the methods or processes and
associated features thereof discussed herein may be implemented or
executed by all or part of a device system, apparatus, or machine,
such as all or a part of any of one or more of the systems,
apparatuses, or machines described herein or a combination or
sub-combination thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0083] It is to be understood that the attached drawings are for
purposes of illustrating aspects of various embodiments and may
include elements that are not to scale.
[0084] FIG. 1 is a schematic representation of a medical device
system according to various example embodiments, where the medical
device system may include a data processing device system, an
input-output device system, and a memory device system, according
to some embodiments.
[0085] FIG. 2A is a cutaway diagram of a heart showing an
electrode-based device system percutaneously placed in a left
atrium of the heart in one particular orientation according to
various example embodiments, the electrode-based device system
optionally being part of the input-output device system of FIG. 1,
according to some embodiments.
[0086] FIG. 2B is a cutaway diagram of a heart showing the
electrode-based device system of FIG. 2A percutaneously placed in a
left atrium of the heart in a different particular orientation
according to various example embodiments.
[0087] FIG. 3A is a partial schematic view of a medical device
system, which may represent one or more implementations of the
medical device system of FIG. 1 in which an expandable structure of
an electrode-based device system is in a delivery or unexpanded
configuration, according to various example embodiments.
[0088] FIG. 3B is a partial schematic view of the medical device
system of FIG. 3A with the expandable structure shown in a deployed
or expanded configuration, according to some embodiments.
[0089] FIG. 3C illustrates a portion of the medical device system
of FIG. 3A as viewed from a different viewing angle, according to
some embodiments.
[0090] FIG. 3D illustrates, according to some embodiments, a single
helical winding configuration of one or more elongate member
portions of a medical device system, such as, but not limited to, a
medical device system of FIG. 1, 2A, 2B, 3A, 3B, or 3C.
[0091] FIG. 3E illustrates, according to some embodiments, a double
helical winding configuration of one or more elongate member
portions of a medical device system, such as, but not limited to, a
medical device system of FIG. 1, 2A, 2B, 3A, 3B, or 3C.
[0092] FIG. 3F illustrates, according to some embodiments, a
non-helical, twisted configuration of one or more elongate member
portions of a medical device system, such as, but not limited to, a
medical device system of FIG. 1, 2A, 2B, 3A, 3B, or 3C.
[0093] FIG. 3G is a partially sectioned view of a percutaneously or
intravascularly deliverable portion of a shaft member and a
plurality of helically configured elongate member portions,
according to some embodiments, of a medical device system, such as,
but not limited to, a medical device system of FIG. 1, 2A, 2B, 3A,
3B, or 3C.
[0094] FIG. 3H is a partially sectioned view of a percutaneously or
intravascularly deliverable portion of the shaft member and the
plurality of helically configured elongate member portions of FIG.
3G, according to some embodiments.
[0095] FIG. 3I illustrates, according to some embodiments, a
transition between a rotationally offset double helical
configuration and a non-twisted, non-helical configuration of
elongate member portions of a medical device system, such as, but
not limited to, a medical device system of FIG. 1, 2A, 2B, 3A, 3B,
or 3C.
[0096] FIG. 3J illustrates, according to some embodiments, a
transition between an axially offset double helical configuration
and a non-twisted, non-helical configuration of elongate member
portions of a medical device system, such as, but not limited to, a
medical device system of FIG. 1, 2A, 2B, 3A, 3B, or 3C.
[0097] FIG. 3K is a representation of various elongate member
portions in a flattened configuration absent a respective helical
configuration, according to some embodiments, the respective
helical configuration being a circumferentially or rotationally
offset double helical configuration, according to some embodiments,
such as, but not limited to, the circumferentially or rotationally
offset double helical configuration of FIG. 3I.
[0098] FIG. 3L is a representation of various elongate member
portions in a flattened configuration absent a respective helical
configuration, according to some embodiments, the respective
helical configuration being a longitudinally or an axially offset
double helical configuration, according to some embodiments, such
as, but not limited to, the longitudinally or axially offset double
helical configuration of FIG. 3J.
[0099] FIG. 4 is a schematic representation of an electrode-based
device that includes a flexible circuit structure, according to
various example embodiments.
DETAILED DESCRIPTION
[0100] Some embodiments of the present invention pertain at least
to medical systems or medical device systems including elongate
members, various portions thereof arranged to form various
structures. In some embodiments, such a structure is manipulable to
change size, shape or both size and shape thereof. In various
embodiments, such a structure is selectively moveable between a
delivery configuration, in which the structure is suitably sized to
be percutaneously or intravascularly deliverable to a bodily
cavity, and a deployed or expanded configuration, in which the
structure is sized too large to be percutaneously or
intravascularly deliverable to the bodily cavity. In some
embodiments, medical device systems include various elongate
members, some particular portions (e.g., first particular portions)
of each of the elongate members form a structure that is
selectively moveable between a first configuration, in which the
structure or the some particular portions are suitably sized to be
percutaneously or intravascularly deliverable to a bodily cavity,
and a second configuration, in which the structure or the some
particular portions are sized too large to be percutaneously or
intravascularly deliverable to the bodily cavity. In some
embodiments, transducer sets (e.g., electrode sets) are located on
the first particular portions of at least some of the elongate
members. According to some embodiments, at least some of the
transducers may be selectively operable to transmit energy (e.g.,
energy sufficient to ablate tissue).
[0101] In some embodiments, the various elongate members include
portions (e.g., second particular portions) other than the first
particular portions described above. In some embodiments, each of
the second particular portions of the various elongate members may
be arranged in a helical configuration or a twisted, non-helical
configuration at least when the structure is in a state in which
the structure is suitably sized to be percutaneously or
intravascularly deliverable to a bodily cavity. As discussed in
more detail below and according to some embodiments, such a helical
configuration or twisted, non-helical configuration improves
bending characteristics and flexibility of the elongate members,
thereby improving the ease by which the structure can be delivered
through tortuous paths through various vessels in a body and by
which the structure can be positioned in a bodily cavity. In some
embodiments, each helical or twisted, non-helical configuration
includes 360 degrees of rotation or more. In some embodiments, each
helical or twisted, non-helical configuration includes 540 degrees
of rotation or more. In some embodiments, each helical or twisted,
non-helical configuration includes 720 degrees of rotation or more.
In some embodiments, the second particular portions of the various
elongate members are arranged in a collective helical configuration
or twisted, non-helical configuration at least when the structure
is in a state in which the structure is suitably sized to be
percutaneously or intravascularly deliverable to a bodily cavity.
In some embodiments, the second particular portions are located
within a catheter shaft member to which the structure is physically
coupled. As described in further detail below, in various
embodiments, the helical configurations or twisted, non-helical
configurations that are comprised by the second particular portions
of the elongate members allow the structure or at least other
particular portions of the elongate members to (a) better negotiate
a tortuous path through a bodily opening leading to a bodily cavity
or (b) provide enhanced positioning of the structure or various
parts of the elongate members within the bodily cavity.
[0102] In the descriptions herein, certain specific details are set
forth in order to provide a thorough understanding of various
embodiments of the invention. However, one skilled in the art will
understand that the invention may be practiced at a more general
level without one or more of these details. In other instances,
well-known structures have not been shown or described in detail to
avoid unnecessarily obscuring descriptions of various embodiments
of the invention.
[0103] Any reference throughout this specification to "one
embodiment", "an embodiment", "an example embodiment", "an
illustrated embodiment", "a particular embodiment", and the like
means that a particular feature, structure or characteristic
described in connection with the embodiment is included in at least
one embodiment. Thus, any appearance of the phrase "in one
embodiment", "in an embodiment", "in an example embodiment", "in
this illustrated embodiment", "in this particular embodiment", or
the like in this specification is not necessarily all referring to
one embodiment or a same embodiment. Furthermore, the particular
features, structures or characteristics of different embodiments
may be combined in any suitable manner to form one or more other
embodiments.
[0104] Unless otherwise explicitly noted or required by context,
the word "or" is used in this disclosure in a non-exclusive sense.
In addition, unless otherwise explicitly noted or required by
context, the word "set" is intended to mean one or more. For
example, the phrase, "a set of objects" means one or more of the
objects. In addition, unless otherwise explicitly noted or required
by context, the word "subset" is intended to mean a set having the
same elements as or fewer elements than the subset's parent or
superset.
[0105] Further, the phrase "at least" is or may be used herein at
times merely to emphasize the possibility that other elements may
exist besides those explicitly listed. However, unless otherwise
explicitly noted (such as by the use of the term "only") or
required by context, non-usage herein of the phrase "at least"
nonetheless includes the possibility that other elements may exist
besides those explicitly listed. For example, the phrase, `based at
least on A` includes A as well as the possibility of one or more
other additional elements besides A. In the same manner, the
phrase, `based on A` includes A, as well as the possibility of one
or more other additional elements besides A. However, the phrase,
`based only on A` includes only A. Similarly, the phrase
`configured at least to A` includes a configuration to perform A,
as well as the possibility of one or more other additional actions
besides A. In the same manner, the phrase `configured to A`
includes a configuration to perform A, as well as the possibility
of one or more other additional actions besides A. However, the
phrase, `configured only to A` means a configuration to perform
only A.
[0106] The word "device", the word "machine", and the phrase
"device system" all are intended to include one or more physical
devices or sub-devices (e.g., pieces of equipment) that interact to
perform one or more functions, regardless of whether such devices
or sub-devices are located within a same housing or different
housings. However, it may be explicitly specified according to
various embodiments that a device or machine or device system
resides entirely within a same housing to exclude embodiments where
the respective device, machine, or device system resides across
different housings. The word "device" may equivalently be referred
to as a "device system" in some embodiments.
[0107] Further, the phrase "in response to" may be used in this
disclosure. For example, this phrase may be used in the following
context, where an event A occurs in response to the occurrence of
an event B. In this regard, such phrase includes, for example, that
at least the occurrence of the event B causes or triggers the event
A.
[0108] In some embodiments, the term "adjacent", the term
"proximate", and the like refer at least to a sufficient closeness
between the objects defined as adjacent, proximate, or the like, to
allow the objects to interact in a designated way. For example, if
object A performs an action on an adjacent or proximate object B,
objects A and B would have at least a sufficient closeness to allow
object A to perform the action on object B. In this regard, some
actions may require contact between the associated objects, such
that if object A performs such an action on an adjacent or
proximate object B, objects A and B would be in contact, for
example, in some instances or embodiments where object A needs to
be in contact with object B to successfully perform the action. In
some embodiments, the term "adjacent", the term "proximate", and
the like additionally or alternatively refers to objects that do
not have another substantially similar object between them. For
example, object A and object B could be considered adjacent or
proximate if they contact each other (and, thus, it could be
considered that no other object is between them), or if they do not
contact each other but no other object that is substantially
similar to object A, object B, or both objects A and B, depending
on the embodiment, is between them. In some embodiments, the term
"adjacent", the term "proximate", and the like additionally or
alternatively refers to at least a sufficient closeness between the
objects defined as adjacent, proximate, and the like, the
sufficient closeness being within a range that does not place any
one or more of the objects into a different or dissimilar region,
or does not change an intended function of any one or more of the
objects or of an encompassing object that includes a set of the
objects. Different embodiments of the present invention adopt
different ones or combinations of the above definitions. Of course,
however, the term "adjacent", the term "proximate", and the like
are not limited to any of the above example definitions, according
to some embodiments. In addition, the term "adjacent" and the term
"proximate" do not have the same definition, according to some
embodiments.
[0109] The phrase "physically coupled" is intended to include, in
some embodiments, a coupling between two objects that involves a
coupling between the two objects that may restrict some form of
movement (e.g., translation or rotation or both translation and
rotation) therebetween. In some embodiments, the two objects
physically contact each other at least in one state of the physical
coupling between the two objects. In some embodiments, the two
objects do not directly physically contact each other at least in
one state of the physical coupling between the two objects (e.g., a
coupler or other coupling member positioned between the two objects
to couple them together). The phrase "rotationally coupled" is
intended to include, in some embodiments, a coupling between two
objects that allows for at least some rotational movement between
the two objects. The phrase "translationally coupled" is intended
to include, in some embodiments, a coupling between two objects
that allows for some form of translational movement between the two
objects. The phrases "fixedly coupled", "permanently coupled", and
the like, are intended to include, in some embodiments, a secure
coupling between two objects that, in some embodiments, does not
involve or include a mechanism configured to release the coupling
of the two objects. The phrases "removably coupled", "detachably
coupled", and the like, are intended to include, in some
embodiments, a coupling between two objects that, in some
embodiments, allows such coupling to be repeatedly disengaged and
re-engaged without damaging the coupling (if a distinct coupling
mechanism exists, e.g., in contrast to an interference fit that
relies on friction), without damaging either or both of the
objects, or without damaging the coupling (if a distinct coupling
mechanism exists) and without damaging either or both of the
objects. The phrase "operatively coupled" is intended to include,
for example, a coupling between two objects that transmits force,
energy, information, or other influence at least from one of the
two objects to the other of the two objects. An operative coupling
does not exclude the possibility of a physical or fixed coupling in
addition to the operative coupling. Unless otherwise explicitly
noted or required by context, for any connection or coupling,
direct or indirect, between components, devices, or other physical
objects described herein, different embodiments include different
ones of the above-described coupling types for such components,
devices, or other physical objects. For example, unless otherwise
explicitly noted or required by context, if a first physical object
is shown in the figures or described in this text as being
connected or coupled, directly or indirectly, to a second physical
object; some embodiments will have the first physical object
fixedly coupled to the second physical object; other embodiments
will have the first physical object rotationally coupled to the
second physical object; other embodiments will have the first
physical object translationally coupled to the second physical
object; other embodiments will have the first physical object
permanently coupled to the second physical object; other
embodiments will have the first physical object removably or
detachably coupled to the second physical object; other embodiments
will have the first physical object not fixedly or permanently
coupled to the second physical object while having the first
physical object physically coupled to the second physical object;
other embodiments will have the first physical object not
physically coupled or fixedly coupled to the second physical
object, but will have the first physical object operatively coupled
to the second physical object; etc.
[0110] The word "fluid" as used in this disclosure should be
understood to include any fluid that can be contained within a
bodily cavity or can flow into or out of, or both into and out of a
bodily cavity via one or more bodily openings positioned in fluid
communication with the bodily cavity. In some embodiments, the word
"fluid" may include fluid that is not inherent to the bodily
cavity, such as saline or other fluid that might be artificially
introduced into the bodily cavity. In some embodiments, the word
"fluid" may include a fluid that may be artificially introduced
into the bodily cavity without the fluid coming into direct contact
with tissue or a naturally occurring bodily fluid (e.g., a fluid
employed in various cryogenic ablation procedures). In the case of
cardiac applications, fluid such as blood will flow into and out of
various intra-cardiac cavities (e.g., a left atrium or right
atrium).
[0111] The phrase "bodily opening" as used in this disclosure
should be understood to include a naturally occurring bodily
opening or channel or lumen; a bodily opening or channel or lumen
formed by an instrument or tool using techniques that may include,
but are not limited to, mechanical, thermal, electrical, chemical,
and exposure or illumination techniques; a bodily opening or
channel or lumen formed by trauma to a body; or various
combinations of one or more of the above or other bodily openings.
Various elements having respective openings, lumens or channels and
positioned within the bodily opening (e.g., a catheter sheath) may
be present in various embodiments. These elements may provide a
passageway through a bodily opening for various devices employed in
various embodiments.
[0112] The words "bodily cavity" as used in this disclosure should
be understood to mean a cavity in a body. The bodily cavity may be
a cavity provided in a bodily organ (e.g., an intra-cardiac cavity
or chamber of a heart). A bodily opening may be provided as a
passageway to a bodily cavity in some embodiments. A bodily cavity
may be provided by a bodily opening in some embodiments.
[0113] The word "tissue" may be used in this disclosure, and tissue
may include non-fluidic tissue and fluidic tissue. Non-fluidic
tissue generally (or predominantly) has solid-like properties, such
as tissue that forms a surface of a body or a surface within a
bodily cavity, a surface of an anatomical feature or a surface of a
feature associated with a bodily opening positioned in fluid
communication with the bodily cavity. Non-fluidic tissue may
include part or all of a tissue wall or membrane that defines a
surface of the bodily cavity. In this regard, the tissue may form
an interior surface of the cavity that at least partially surrounds
a fluid within the cavity. In the case of cardiac applications,
non-fluidic tissue may include tissue used to form an interior
surface of an intra-cardiac cavity such as a left atrium or right
atrium. Fluidic tissue, on the other hand, generally (or
predominantly) has fluid-like properties (as compared to solid-like
properties). An example of fluidic tissue is blood. In this regard,
it should be noted that fluidic tissue may have some solid-like
component(s) (e.g., fluidic tissue may include solid-like
components), and non-fluidic tissue may have some fluid-like
component(s) (e.g., non-fluidic tissue may include fluidic tissue
within it). Unless otherwise explicitly noted or required by
context, the word "tissue" should include non-fluidic tissue and
fluidic tissue. However, some contexts where the word "tissue"
would not include fluidic tissue are when tissue ablation is
discussed, and ablation of fluidic tissue could be undesired, as
discussed below. In various embodiments, non-fluidic tissue does
not include excised tissue.
[0114] The word "ablation" as used in this disclosure should be
understood to include any disruption to certain properties of
tissue. Most commonly, the disruption is to the electrical
conductivity of tissue and may be achieved by heating, which may be
generated with resistive or radio-frequency (RF) techniques for
example. Other properties of tissue, such as mechanical or
chemical, and other means of disruption, such as optical or the use
of cryogenic fluids are included when the term "ablation" is used.
In some embodiments, electroporation techniques are included when
the term "ablation" is used. In some embodiments, ablative power
levels may be within the range of 3 W to 5 W (as compared, e.g., to
a non-tissue-ablative power level range of 50 mW to 60 mW that may
be used for typical impedance determinations). In some embodiments,
ratios of employed ablative power levels to employed
non-tissue-ablative power levels (e.g., used for typical impedance
determinations) may be: at least equal to or greater than 50:1 in
various embodiments; at least greater than 60:1 in some
embodiments; at least greater than 80:1 in other various
embodiments; and at least greater than 100:1 in yet other
embodiments. In some embodiments, systems are configured to perform
ablation of non-fluidic tissue while avoiding the delivery of
excessive energy to fluidic tissue because energy that is
sufficient to ablate non-fluidic tissue may also impact fluidic
tissue in some circumstances. For example, energy that is
sufficient to ablate non-fluidic tissue, in some circumstances, may
cause blood (an example of fluidic tissue) to coagulate. In these
and other embodiments where ablative energy transferred to fluidic
tissue is not desired, it should be understood that any statement
or reference to the `ablation of tissue` or the like in these
contexts is intended to refer to ablation of non-fluidic tissue, as
opposed to ablation of fluidic tissue.
[0115] The term "transducer" as used in this disclosure should be
interpreted broadly as any device capable, for example, of
distinguishing between fluid and non-fluidic tissue, sensing
temperature, creating heat, ablating tissue and measuring
electrical activity of a tissue surface, stimulating tissue or any
combination thereof. A transducer may convert input energy of one
form into output energy of another form. Without limitation, a
transducer may include an electrode, and references to a
"transducer" herein may be replaced with "electrode" according to
some embodiments. Without limitation, a transducer may include an
electrode or a sensing device, or both an electrode and a sensing
device. An electrode, in some embodiments, may be configured at
least as a sensing device. Because a transducer may include an
electrode according to various embodiments, any reference herein to
a transducer may also imply a reference to an electrode, or vice
versa. A transducer may be constructed from several parts, which
may be discrete components or may be integrally formed. In some
embodiments, an ablative element configured to apply energy
sufficient for tissue ablation may be provided at least in part by
a transducer.
[0116] The phrase "derivative thereof" and the like is or may be
used herein at times in the context of a derivative of data or
information merely to emphasize the possibility that such data or
information may be modified or subject to one or more operations.
For example, if a device generates first data for display, the
process of converting the generated first data into a format
capable of being displayed may alter the first data. This altered
form of the first data may be considered a derivative of the first
data. For instance, the first data may be a one-dimensional array
of numbers, but the display of the first data may be a color-coded
bar chart representing the numbers in the array. For another
example, if the above-mentioned first data is transmitted over a
network, the process of converting the first data into a format
acceptable for network transmission or understanding by a receiving
device may alter the first data. As before, this altered form of
the first data may be considered a derivative of the first data.
For yet another example, generated first data may undergo a
mathematical operation, a scaling, or a combining with other data
to generate other data that may be considered derived from the
first data. In this regard, it can be seen that data is commonly
changing in form or being combined with other data throughout its
movement through one or more data processing device systems, and
any reference to information or data herein is intended to include
these and like changes, regardless of whether or not the phrase
"derivative thereof" or the like is used in reference to the
information or data, unless otherwise required by context. As
indicated above, usage of the phrase "or a derivative thereof" or
the like merely emphasizes the possibility of such changes.
Accordingly, the addition of or deletion of the phrase "or a
derivative thereof" or the like should have no impact on the
interpretation of the respective data or information. For example,
the above-discussed color-coded bar chart may be considered a
derivative of the respective first data or may be considered the
respective first data itself.
[0117] The term "program" in this disclosure should be interpreted
as a set of instructions or modules that may be executed by one or
more components in a system, such as a controller system or data
processing device system, in order to cause the system to perform
one or more operations. The set of instructions or modules may be
stored by any kind of memory device, such as those described
subsequently with respect to the memory device system 130, 330, or
both, shown in FIGS. 1, 3A, and 3B, respectively. In addition, this
disclosure may describe or similarly describe that the instructions
or modules of a program are configured to cause the performance of
an action. The phrase "configured to" in this context is intended
to include at least (a) instructions or modules that are presently
in a form executable by one or more data processing devices to
cause performance of the action (e.g., in the case where the
instructions or modules are in a compiled and unencrypted form
ready for execution), and (b) instructions or modules that are
presently in a form not executable by the one or more data
processing devices, but could be translated into a particular form
executable by the one or more data processing devices to cause
performance of the action (e.g., in the case where the instructions
or modules are encrypted in a non-executable manner, but through
performance of a decryption process, would be translated into a
form ready for execution). Such descriptions should be deemed to be
equivalent to describing that the instructions or modules are
configured to cause the performance of the action. The word
"module" may be defined as a set of instructions. The word
"program" and the word "module" may each be interpreted to include
multiple sub-programs or multiple sub-modules, respectively. In
this regard, reference to a program or a module may be considered
to refer to multiple programs or multiple modules.
[0118] Further, it is understood that information or data may be
operated upon, manipulated, or converted into different forms as it
moves through various devices or workflows. In this regard, unless
otherwise explicitly noted or required by context, it is intended
that any reference herein to information or data includes
modifications to that information or data. For example, "data X"
may be encrypted for transmission, and a reference to "data X" is
intended to include both its encrypted and unencrypted forms,
unless otherwise required or indicated by context. For another
example, "image information Y" may undergo a noise filtering
process, and a reference to "image information Y" is intended to
include both the pre-processed form and the noise-filtered form,
unless otherwise required or indicated by context. In other words,
both the pre-processed form and the noise-filtered form are
considered to be "image information Y", unless otherwise required
or indicated by context. In order to stress this point, the phrase
"or a derivative thereof" or the like may be used herein.
Continuing the preceding example, the phrase "image information Y
or a derivative thereof" refers to both the pre-processed form and
the noise-filtered form of "image information Y", unless otherwise
required or indicated by context, with the noise-filtered form
potentially being considered a derivative of "image information Y".
However, non-usage of the phrase "or a derivative thereof" or the
like nonetheless includes derivatives or modifications of
information or data just as usage of such a phrase does, as such a
phrase, when used, is merely used for emphasis.
[0119] The term "helical" in this disclosure should be interpreted
as having the form of a helix, in some embodiments, or, in some
embodiments, a progressive winding around a three-dimensional shape
like, for example, a wire wound around a cylinder in some
embodiments, or a cone in some embodiments, or some other shape in
other embodiments, in a corkscrew-like or screw thread-like manner.
Unlike spiral or volute forms confined to a single plane, the term
"helical" in this disclosure should be interpreted as exhibiting
the rotational characteristic of a helix, where the rotation occurs
about an axis (e.g., a longitudinal axis) of a three dimensional
shape as the rotation extends along the axis, like the example of a
wire winding progressively around a cylinder and the cylinder's
longitudinal axis. In this regard, the axis may be referred to as
the rotational axis of the helical object. In addition, the term
"helical" in this disclosure should be interpreted as exhibiting
the rotational characteristic of a helix, where the rotation is
spaced from the axis (e.g., the longitudinal axis) of the three
dimensional shape around which the rotation winds. In this regard,
in some embodiments, it is considered that a longitudinal axis of a
three dimensional shape about which the rotation occurs is located
at a center of each successive cross-section of the three
dimensional shape along the longitudinal direction of the three
dimensional shape. Accordingly, the longitudinal axis may be
considered to be the rotational axis (or axis of rotation) of the
helical object and may be considered to bend with the three
dimensional shape, for example, in the case of a long, narrow tube
that bends, where the longitudinal axis of the long, narrow tube
bends with the bending of the long, narrow tube.
[0120] The phrase, "twisted, non-helical" and similar phrases used
in this disclosure should be interpreted as a twisting that
intersects its rotational axis (or axis of rotation). In other
words, a "twisted, non-helical" rotation occurs about a rotational
axis, but intersects the rotational axis, whereas a helical
rotation occurs about a rotational axis, but is spaced from and
does not intersect the rotational axis. As with the above
discussion regarding the rotational axis of a helical object
possibly bending in some embodiments, the rotational axis of a
twisted, non-helical configuration may also bend in some
embodiments.
[0121] FIG. 1 schematically illustrates at least part of a medical
device system 100 according to some embodiments. In some
embodiments, the medical device system 100 includes a data
processing device system 110, an input-output device system 120,
and a processor-accessible memory device system 130. The
processor-accessible memory device system 130 and the input-output
device system 120 are communicatively connected to the data
processing device system 110.
[0122] The data processing device system 110 includes one or more
data processing devices that implement or execute, in conjunction
with other devices, such as those in the system 100, methods of
various embodiments that may be employed by various aspects
described in this disclosure. Each of the phrases "data processing
device", "data processor", "processor", and "computer" and the like
is intended to include any data processing device, such as a
central processing unit ("CPU"), a desktop computer, a laptop
computer, a mainframe computer, a tablet computer such as an iPad
(Trademark Apple Inc., Cupertino Calif.), a personal digital
assistant, a cellular phone, a smartphone, or any other device for
processing data, managing data, or handling data, whether
implemented with electrical, magnetic, optical, biological
components, or otherwise.
[0123] The memory device system 130 includes one or more
processor-accessible memory devices configured to store
information, including the information needed to execute the
methods associated with various embodiments. The memory device
system 130 may be a distributed processor-accessible memory device
system including multiple processor-accessible memory devices
communicatively connected to the data processing device system 110
via a plurality of computers and/or devices. On the other hand, the
memory device system 130 need not be a distributed
processor-accessible memory system and, consequently, may include
one or more processor-accessible memory devices located within a
single data processing device.
[0124] Each of the phrases "processor-accessible memory" and
"processor-accessible memory device" and the like is intended to
include any processor-accessible data storage device, whether
volatile or nonvolatile, electronic, magnetic, optical, or
otherwise, including but not limited to, registers, floppy disks,
hard disks, Compact Discs, DVDs, flash memories, ROMs, and RAMs. In
some embodiments, each of the phrases "processor-accessible memory"
and "processor-accessible memory device" is intended to include or
be a processor-accessible (or computer-readable) data storage
medium. In some embodiments, each of the phrases
"processor-accessible memory" and "processor-accessible memory
device" is intended to include or be a non-transitory
processor-accessible (or computer-readable) data storage medium. In
some embodiments, the processor-accessible memory device system 130
may be considered to include or be a non-transitory
processor-accessible (or computer-readable) data storage medium
system. And, in some embodiments, the memory device system 130 may
be considered to include or be a non-transitory
processor-accessible (or computer-readable) storage medium system
or data storage medium system including or consisting of one or
more non-transitory processor-accessible (or computer-readable)
storage or data storage mediums.
[0125] The phrase "communicatively connected" is intended to
include any type of connection, whether wired or wireless, between
devices, data processors, or programs in which data may be
communicated. Further, the phrase "communicatively connected" is
intended to include a connection between devices or programs within
a single data processor, a connection between devices or programs
located in different data processors, and a connection between
devices not located in data processors at all. In this regard,
although the memory device system 130 is shown separately from the
data processing device system 110 and the input-output device
system 120, one skilled in the art will appreciate that the memory
device system 130 may be located completely or partially within the
data processing device system 110 or the input-output device system
120. Further in this regard, although the input-output device
system 120 is shown separately from the data processing device
system 110 and the memory device system 130, one skilled in the art
will appreciate that such system may be located completely or
partially within the data processing device system 110 or the
memory device system 130, depending upon the contents of the
input-output device system 120. Further still, the data processing
device system 110, the input-output device system 120, and the
memory device system 130 may be located entirely within the same
device or housing or may be separately located, but communicatively
connected, among different devices or housings. In the case where
the data processing device system 110, the input-output device
system 120, and the memory device system 130 are located within the
same device, the system 100 of FIG. 1 may be implemented by a
single application-specific integrated circuit (ASIC) in some
embodiments.
[0126] The input-output device system 120 may include a mouse, a
keyboard, a touch screen, another computer, or any device or
combination of devices from which a desired selection, desired
information, desired instructions, or any other desired data is
input to the data processing device system 110. The input-output
device system 120 may include a user-activatable control system
that is responsive to a user action, such as actions from a care
provider such as a physician or technician. The input-output device
system 120 may include any suitable interface for receiving
information, instructions or any data from other devices and
systems described in various ones of the embodiments. In this
regard, the input-output device system 120 may include various ones
of other systems described in various embodiments. For example, the
input-output device system 120 may include at least a portion of a
medical system, transducer-based device system, or an
electrode-based device system described herein. The phrase
"transducer-based device system" is intended to include one or more
physical devices or systems that include various transducers.
Similarly, the phrase "electrode-based device system" is intended
to include one or more physical devices or systems that include
various electrodes. In this regard, the phrases "transducer-based
device system" and "electrode-based device system" may be used
interchangeably in accordance with various embodiments. Similarly,
the phrases "transducer-based device" and "electrode-based device"
may be used interchangeably in accordance with various
embodiments.
[0127] The input-output device system 120 also may include an
image-generating device system, a display device system, a speaker
device system, a processor-accessible memory device system, or any
device or combination of devices to which information,
instructions, or any other data is output from the data processing
device system 110. In this regard, if the input-output device
system 120 includes a processor-accessible memory device, such
memory device may or may not form part or all of the memory device
system 130. The input-output device system 120 may include any
suitable interface for outputting information, instructions or data
to other devices and systems described in various ones of the
embodiments. In this regard, the input-output device system may
include various other devices or systems described in various
embodiments.
[0128] FIG. 2A shows an electrode-based device system 300, which
may be all or part of a medical system or medical device system,
and which may be included in the input-output device system 120 of
FIG. 1, according to some embodiments. Because, as described in
more detail below with respect to FIG. 4, electrodes may be part of
transducers, according to some embodiments, the system 300 may also
be considered a transducer-based device system in some
embodiments.
[0129] Such a system 300 may be beneficial for, among other things,
investigating or treating a bodily organ, for example, a heart 202,
according to some example embodiments. The electrode-based device
system 300 may include a frame or structure 308 that may be
percutaneously or intravascularly inserted into a portion of the
heart 202, such as an intra-cardiac cavity like left atrium 204. In
some embodiments, the structure 308 is formed at least by a
plurality of elongate members 304 (two called out in FIG. 2A) which
provide the transducers 306. Although the embodiments associated
with FIGS. 2A, 2B, 3A, 3B, and 3C show embodiments of systems 300
with ten elongate members 304, different embodiments may have
different numbers of elongate members 304. For example, embodiments
associated with FIGS. 3G, 3H, 3K, and 3L show embodiments of system
300 with eight elongate members 304.
[0130] Returning to the example of FIG. 2A, the electrode-based
device system 300 includes catheter 314 inserted via the inferior
vena cava 208 and penetrating through a bodily opening in
transatrial septum 210 from right atrium 212. In other embodiments,
other paths may be taken.
[0131] Catheter 314 may include an elongated flexible rod or shaft
member 316 appropriately sized to be deliverable percutaneously or
intravascularly. According to various embodiments, the shaft member
316 may be employable or configured to percutaneously or
intravascularly deliver the structure 308 through a bodily opening
(e.g., the bodily opening in transatrial septum 210) leading to a
bodily cavity (e.g., left atrium 204 of the heart 202) at least in
response to translation of at least part of the shaft member 316.
The shaft member 316 may include a shaft proximal end 316a (not
shown in FIG. 2A, but shown, for example, in FIG. 3A. The shaft
member 316 may also include a shaft distal end 316b (shown, for
example, in FIG. 3A), with the structure 308 physically coupled to
the shaft member 316 at least proximate the shaft distal end 316b.
In addition, the shaft member 316 may include an elongated portion
316c (shown, for example, in FIG. 3A) extending between the shaft
proximal end 316a and the shaft distal end 316b. According to some
embodiments, the shaft member 316 includes a length extending from
the proximal end 316a to the distal end 316b, the length of the
shaft member 316 sufficient to position the proximal end 316a
outside a body comprising the bodily cavity during a state in which
the structure 308 is positioned in the bodily cavity.
[0132] In various embodiments, the shaft member 316 is physically
coupled to the structure 308 at a location fixed with respect to
the shaft distal end 316b. In various embodiments, the physically
coupling between the shaft member 316 and the structure 308 allows
for a movement (e.g., a translation) of the structure 308 in
response to a movement (e.g., a translation) of at least part of
the shaft member 316. In some embodiments, the structure 308 is
physically coupled to shaft member 316 at a location that does not
vary with respect to the shaft distal end 316b in response to a
movement (e.g., a translation) of at least part of the shaft member
316. In some embodiments, the shaft member 316 is fixedly coupled
to the structure 308. For example, as described in more detail
below with respect to FIGS. 3G and 3H, the shaft member 316 may
terminate with a collar 316b1 (not shown in FIGS. 3A, 3B, but shown
in FIGS. 3G and 3H) at the shaft distal end 316b. In this regard,
the collar 316b1 or other securing mechanism may physically or
fixedly couple the shaft member 316 to the plurality of elongate
members 304 forming the structure 308, according to some
embodiments. Also in this regard, the shaft member 316 may be
physically coupled to the plurality of elongate members 304, such
that a respective location at which the shaft member 316 is
physically coupled (e.g., at the collar 316b1) to each elongate
member 304 is fixed with respect to the shaft distal end 316b of
the shaft member 316, according to some embodiments.
[0133] Various portions of catheter 314 may be steerable. Catheter
314 may include one or more lumens. The lumen(s) may carry one or
more communications or power paths, or both. For example, the
lumens(s) may carry one or more electrical conductors or control
leads 317. Electrical conductors 317 provide electrical connections
for system 300 that are accessible externally from a patient in
which the electrode-based device system 300 is inserted, according
to some embodiments. In some embodiments, the electrical conductors
317 form part of various elongate members (e.g., elongate members
304 described below). In some embodiments, the electrical
conductors 317 include, or form part of, various flexible circuit
structures (e.g., as described in FIG. 4, below).
[0134] In some embodiments, the electrical conductors 317 may
provide electrical connections to transducers 306 (three called out
in FIG. 2A) that respectively may include one or more electrodes,
and optionally one or more other devices, (e.g., both discussed
with respect to FIG. 4, below) configured to, among other things,
provide stimulation (e.g., electrical stimulation that may include
pinging or pacing) to tissue within a bodily cavity (e.g., left
atrium 204), ablate tissue in a desired pattern within the bodily
cavity, sense characteristics of tissue (e.g., electrophysiological
activity, convective cooling, permittivity, force, temperature,
impedance, thickness, or a combination thereof) within the bodily
cavity, or a combination thereof or sense various other animate or
non-animate physical characteristics.
[0135] The sensing of characteristics may, among other things, be
configured to distinguish between fluid, such as fluidic tissue
(e.g., blood), and non-fluidic tissue forming an interior surface
of a bodily cavity (e.g., left atrium 204); may be configured to
map the cavity, for example, using positions of openings or ports
into and out of the cavity; may be configured to determine a
position or orientation (e.g., pose), or both of a portion of the
device system 300 in the bodily cavity; may be configured to
indicate whether an ablation has been successful; or a combination
thereof.
[0136] Electrode-based device system 300 may include the frame or
structure 308 on which the plurality of transducers 306 are located
and which may assume an unexpanded or delivery configuration (e.g.,
FIGS. 3A, 3G, and 3H, discussed below) for delivery to left atrium
204. Structure 308 may be deployed or expanded (e.g., shown in a
deployed or expanded configuration in FIG. 2A, as well as at least
FIGS. 2B, 3B, and 3C, which are discussed below) upon delivery to
left atrium 204. In this regard, in some embodiments, the
electrode-based device system 300 or the structure 308 thereof is
selectively moveable between a delivery or unexpanded configuration
(e.g., FIGS. 3A, 3G, and 3H, discussed below) and a deployed or
expanded configuration (e.g., FIG. 2A, as well as at least FIGS.
2B, 3B, and 3C discussed below). U.S. Pat. No. 9,452,016, issued
Sep. 27, 2016, includes disclosures regarding various actuators,
control lines, and other mechanisms by which a transducer or
electrode-based device may be selectively moveable between a
delivery or unexpanded configuration and a deployed or expanded
configuration, and U.S. Pat. No. 9,452,016, issued Sep. 27, 2016 is
hereby incorporated herein by reference in its entirety. In the
delivery or unexpanded configuration, a portion (e.g., the
structure 308) of the device system 300 is sized to be
percutaneously or intravascularly deliverable to a bodily cavity,
e.g., via passage thereof through a bodily opening leading to the
bodily cavity, according to some embodiments. In some embodiments
where a first particular portion of each elongate member 304 is
included in the structure 308, the first portions of the elongate
members 304 are sized to be percutaneously or intravascularly
deliverable to the bodily cavity when the structure 308 is in the
delivery or unexpanded configuration. In the deployed or expanded
configuration, a portion (e.g., the structure 308 or first
particular portions 309a of elongate members 304 discussed below)
of the device system 300 is sized too large to be percutaneously or
intravascularly deliverable to the bodily cavity and to allow
passage thereof through the bodily opening leading to the bodily
cavity. In some embodiments where a first particular portion 309a
of each elongate member 304 is included in the structure 308, the
first portions of the elongate members 304 are sized too large to
be percutaneously or intravascularly deliverable to the bodily
cavity and to allow passage thereof through the bodily opening
leading to the bodily cavity.
[0137] An example of an expanded or deployed configuration is when
the portion of the electrode-based device system (e.g., the
structure 308) is in its intended-deployed-operational state inside
the bodily cavity. Another example of the expanded or deployed
configuration is when the portion of the electrode-based device
system 300 is being changed from the delivery configuration to the
intended-deployed-operational state to a point where the portion of
the device system now has a size too large for passage through the
bodily opening leading to the bodily cavity. In some embodiments,
the portion of the electrode-based device system 300 has a size or
dimension when the structure 308 is in the expanded or deployed
configuration that is larger than the corresponding size or
dimension of the portion of the electrode-based device system 300
in the delivery configuration. Further, in some embodiments, when
the portion (e.g., the structure 308) is in the expanded or
deployed configuration in the left atrium 204, various ones of a
plurality of transducers 306 may be positionable proximate the
interior surface formed by non-fluidic tissue 222 of left atrium
204. In some embodiments, when the portion (e.g., the structure
308) is in the expanded or deployed configuration in the left
atrium 204, various ones of plurality of transducers 306 may be
positionable such that a physical portion of each of the various
ones of the transducers 306 is configured to contact the interior
surface formed by non-fluidic tissue 222 of left atrium 204. In
some embodiments, at least some of the transducers 306 are
configured to sense a physical characteristic of a fluid (i.e.,
blood), non-fluidic tissue 222 (i.e., cardiac wall tissue), or
both, that may be used to determine a position of a particular
anatomical feature (e.g., a cardiac port provided by a pulmonary
vein or a cardiac valve). In some embodiments, at least some of the
transducers 306 are configured to sense a physical characteristic
(e.g., an electric or magnetic field created by various locator or
navigation systems) to determine a position or orientation (i.e.,
pose), or both, of a portion of a device system 300 within, or with
respect to left atrium 204. For example, transducers 306 may be
configured to determine a location of pulmonary vein ostia (not
shown) or a mitral valve 226, or both. In some embodiments, at
least some of the transducers 306 may be controlled to selectively
ablate portions of the non-fluidic tissue 222. For example, some of
the transducers 306 may be controlled to ablate a pattern or path
around various ones of the bodily openings, ports or pulmonary vein
ostia, for instance, to reduce or eliminate the occurrence of
atrial fibrillation. Each of various ones of the transducers 306
may include an electrode in various embodiments, as described below
with respect to FIG. 4, for example.
[0138] Each of FIGS. 3A and 3B is a partial schematic
representation of a medical device system, which may represent one
or more implementations of the medical device system 100 of FIG. 1,
according to some embodiments. The medical system of each of these
figures may include the electrode-based device system 300, which
itself may include several hundred transducers 306 or electrodes
315 (only a few called out in the figures), but need not include
that many. FIG. 3A illustrates the electrode-based device system
300 in a delivery or unexpanded configuration, according to various
example embodiments, and FIGS. 3B and 3C illustrate the
electrode-based device system 300 in a deployed or expanded
configuration, according to some embodiments.
[0139] In this regard, the electrode-based device system 300 may
include a plurality of elongate members 304 (only a few called out
in the figures) and a plurality of transducers 306 or electrodes
315 (only a few called out in the figures). In some embodiments,
the transducers 306 or electrodes 315 have the configuration of the
transducers 306 or electrodes 315 in FIG. 2A. In some embodiments,
the transducers 306 or electrodes 315 are formed as part of,
coupled to, or are located on, at least some of the elongate
members 304. In this regard, in some embodiments, each elongate
member 304 has located thereon a respective set of one or more of
the transducers 306. Accordingly, the transducers 306 located on a
single elongate member 304 may be considered a set of transducers
in some embodiments. In this regard, it may be considered that a
plurality of sets of one or more transducers 306 exists, with, in
some embodiments, each transducer set being located on a respective
elongate member 304. As discussed in more detail below with respect
to FIG. 4, the transducers 306 may include electrodes 315, such
that each transducer 306 includes a respective electrode 315
according to some embodiments. In some embodiments, the transducers
306 or electrodes 315 are operable to be energized (e.g., via an
energy source device system 340, discussed below) to interact with
tissue within the bodily cavity.
[0140] In some embodiments, the elongate members 304 are arranged
as, or form at least part of, the frame or structure 308 that is
selectively moveable between an unexpanded or delivery
configuration (e.g., as shown in FIG. 3A) and an expanded or
deployed configuration (e.g., as shown in FIGS. 3B and 3C) that may
be used to position or distribute particular portions of elongate
members 304 at various locations within a bodily cavity (e.g.,
locations away from a tissue surface within the bodily cavity,
locations against a tissue surface, or locations at least proximate
the tissue surface).
[0141] In some embodiments, the structure 308 has a size in the
unexpanded or delivery configuration suitable to allow the
structure 308 to be percutaneously or intravascularly deliverable
at least partially through a bodily opening (e.g., via catheter
sheath 312, shown in FIG. 3A, but not in the other figures for
purposes of clarity) to the bodily cavity. In some embodiments,
structure 308 has a size when the structure 308 is in the expanded
or deployed configuration too large to allow the structure to be
intravascularly or percutaneously deliverable through a bodily
opening (e.g., via catheter sheath 312) to the bodily cavity.
[0142] The elongate members 304 may form part of or include a
flexible circuit structure (i.e., also known as a flexible printed
circuit board (PCB) circuit). The elongate members 304 may include
a plurality of different material layers. Each of the elongate
members 304 may include a plurality of different material layers.
The structure 308 may include a shape memory material, for instance
Nitinol. The structure 308 may include a metallic material, for
instance stainless steel, or non-metallic material, for instance
polyimide, or the structure 308 may include both a metallic and a
non-metallic material by way of non-limiting example. The
incorporation of a specific material into structure 308 may be
motivated by various factors including the specific requirements of
each of the unexpanded or delivery configuration and expanded or
deployed configuration, the required position or orientation (i.e.,
pose) or both of structure 308 in the bodily cavity, or the
requirements for successful ablation of a desired pattern. For
clarity, not all of the elongate members shown in the deployed or
expanded configuration shown in FIG. 3B are shown in the structure
308 in the delivery configuration shown in FIG. 3A.
[0143] One or more transducers of the plurality of transducers 306
is or are positionable within a bodily cavity, for example, by
positioning of the structure 308. For instance, in some
embodiments, various ones of the transducers 306 are able to be
positioned in a bodily cavity by movement into, within, or into and
within the bodily cavity, with or without a change in a
configuration of the plurality of transducers 306 (e.g., a change
in a configuration of the structure 308 causes a change in
configuration of the transducers 306 in some embodiments). In some
embodiments, the plurality of transducers 306 is arrangeable to
form a two- or three-dimensional distribution, grid or array
capable of mapping, ablating or stimulating or otherwise
interacting with an inside surface of a bodily cavity or lumen
without requiring mechanical scanning.
[0144] As shown for example in FIG. 3A, the plurality of
transducers 306 is arranged in a distribution receivable in a
bodily cavity (not shown in FIG. 3A). As shown for example, in FIG.
3A, the plurality of transducers 306 is arranged in a distribution
suitable for delivery to a bodily cavity, according to some
embodiments. Also as shown for example in FIG. 3A, the structure
308, when in the delivery configuration, arranges at least part of
each respective elongate member of the plurality of elongate
members 304 to be advanced with a distal end (also referred to as
the second end) 305 of the respective elongate member 304 ahead of
a proximal portion 307 of the respective elongate member 304 toward
the bodily cavity, according to some embodiments. In some
embodiments, the proximal portion 307 or portions thereof (e.g.,
307a, 307b, or both) is or are at least part of proximal portion
309c, proximal portion 309d, or both (discussed in more detail
below with respect to e.g., at least FIG. 3D and afterwards). In
some embodiments, proximal portion 307 is located within shaft
member 316 (e.g., within a lumen in shaft member 316). In some
embodiments, the proximal portion 307 may be considered an external
proximal portion, because it exists just external of the shaft
member 316 (for example as described below), according to some
embodiments.
[0145] FIG. 3B shows another proximal portion 307a of each
respective elongate member 304 located within the shaft member 316
just proximal a point or location where the helical configuration
or twisted, non-helical configuration discussed below (e.g., with
respect to FIGS. 3D, 3E, 3F, 3G, 3H, 3I, 3J, 3K, and 3L) begins
turning within the shaft member 316. (All or one or more sections
of the shaft member 316 have been removed in at least FIGS. 2A, 2B,
3A, 3B, 3D, 3E, 3F, 3G, 3H, 3I, and 3J to show what is occurring
within the shaft member 316 at the removed portions.) Accordingly,
the proximal portion 307a may be considered a pre-helix or
pre-twist intermediate internal proximal portion of each respective
elongate member 304. Also shown in FIG. 3B is yet another proximal
portion 307b of each respective elongate member 304 located at a
proximal end of each respective elongate member 304 where each
respective elongate member 304 terminates, e.g., at the connector
321, at the controller 324, or at the data processing device system
310, according to various embodiments. Accordingly, the proximal
portion 307b of each respective elongate member 304 may be
considered a respective proximal end of the respective elongate
member 304. (Although the arrows 307a, 307b point near an exterior
of the shaft member in FIG. 3B, such arrows are intended to refer
to an interior where the elongate members reside according to some
embodiments.) In some embodiments, the proximal portion (e.g. 307a,
307b) of each respective elongate member 304 includes portions of
various ones of conductors 317.
[0146] In some embodiments, as shown, for example, in FIG. 3A, each
of the plurality of elongate members 304 is arranged to be
percutaneously or intravascularly deliverable distal end first or
distal end ahead of various ones of the proximal portions 307 to
the bodily cavity when the structure is in the delivery
configuration. In some embodiments, at least some of the elongate
members 304 are arranged to be percutaneously or intravascularly
deliverable with a portion thereof other than the distal end
delivered first to the bodily cavity when the structure is in the
delivery configuration.
[0147] FIG. 4 is a schematic side elevation view of at least a
portion of an electrode-based device system 400 that includes a
flexible circuit structure 401 that is employed to provide a
plurality of transducers 406 (two called out) according to various
example embodiments. The portion of the electrode-based device
system 400 may form part of each of one or more or all elongate
members 304, according to some embodiments. In some embodiments,
the transducers 406 correspond to the transducers 306. In some
embodiments, at least a particular portion of the flexible circuit
structure 401 may form part of a structure (e.g., structure 308)
that is selectively moveable between a delivery configuration sized
for percutaneous or intravascular delivery and an expanded or
deployed configuration sized too large for percutaneous or
intravascular delivery. In some embodiments, at least a particular
portion of the flexible circuit structure 401 may be located on, or
form at least part of, a structural component (e.g., elongate
member 304) of an electrode-based device system (e.g.,
electrode-based device system 300). In some embodiments, at least
part of the flexible circuit structure 401 may provide each
particular portion of an elongate member. For each respective
elongate member 304, the flexible circuit structure 401 may include
or may form at least part of a respective portion (e.g., the
respective portion 309a (discussed in more detail below), the
respective portion 309b (discussed in more detail below), the
respective portion 309c (discussed in more detail below), or a
combination of two or all of such portions or other portions
described herein) of the respective elongate member 304. For
example, in some embodiments, the flexible circuit structure 401
may begin at a connection with data processing device system 310
and extend at least to and include the transducers 306 of the
respective elongate member 304. For another example, in some
embodiments, conductors may be connected at one end to the data
processing device system 310 and extend through some proximal
portion of the shaft member 316 and be connected at the other end
to the flexible circuit structure 401 at some intermediate internal
proximal portion (e.g., 307a or other portion within the shaft
member 316) where the flexible circuit structure 401 and its
respective elongate member 304 begin. In some embodiments, for each
respective elongate member 304, a multi-layer structure (e.g.,
flexible circuit structure 401) may include or may form at least
part of a respective portion (e.g., the respective portion 309a
(discussed in more detail below), the respective portion 309b
(discussed in more detail below), the respective portion 309c
(discussed in more detail below), or a combination of two or all of
such portions or other portions described herein) of the respective
elongate member 304. According to some embodiments, for each
respective elongate member 304, the flexible circuit structure 401
may extend or exist from a proximal end of the respective elongate
member 304 to a distal end of the respective elongate member 304.
According to some embodiments, for each respective elongate member
304, the flexible circuit structure 401 may proximally begin at a
proximal end of the respective elongate member 304 and end at a
distal end of the respective elongate member 304. In some
embodiments, for each particular elongate member 304, the
particular elongate member 304 includes the flexible circuit
structure 401 extending between the proximal end of the particular
elongate member 304 and the distal end of the particular elongate
member 304. In some embodiments, for each particular elongate
member 304, the particular elongate member 304 includes the
flexible circuit structure 401 extending between the proximal
portion 307, the proximal portion 307a, or the proximal portion
307b, and the distal end 305 of the particular elongate member
304.
[0148] In some embodiments, for each particular elongate member
304, the particular elongate member 304 includes a flexible circuit
structure 401 that includes a plurality of separately formed
portions, each of the portions physically and electrically coupled
together to form flexible circuit structure 401 extending between
the proximal end of the particular elongate member 304 and the
distal end of the particular elongate member 304. The use of
physically and electrically coupled, but separately formed portions
may be motivated for different reasons including limitations in
flexible printed circuit manufacturing techniques in forming a
single flexible circuit structure 401 having sufficient length to
extend between the proximal end of the particular elongate member
304 and the distal end of the particular elongate member 304.
[0149] In some embodiments, at least a particular portion of the
flexible circuit structure 401 may form, provide, or be connected
to at least part of one or more conductors (e.g., conductors 317,
one or more of which may be connected to leads 410a, 410b in FIG.
4, discussed in more detail below) arranged to provide a power or
communications path to various ones of the transducers 406). It is
noted that conductors provided by the flexible circuit structure
401 need not be confined to portions of flexible circuit structure
401 forming part of, or positioned at least proximate the structure
(e.g., structure 308), but rather may be configured to extend over
a substantial portion of a path extending from various ones of the
transducers 306 located within a bodily cavity to a location
outside a body that comprises the bodily cavity. Such configuration
may provide enhanced reliability from a reduced number of required
connectors as well as reducing various economic costs associated
with the system.
[0150] The flexible circuit structure 401 may be formed by various
techniques including flexible printed circuit techniques. In some
embodiments, the flexible circuit structure 401 includes various
layers including flexible layers 403 (three called out in FIG. 4 as
reference symbols 403a, 403b, and 403c). In some embodiments, each
of the flexible layers 403 includes an electrical insulator
material (e.g., polyimide). One or more of the flexible layers 403
may include a different material than another of the flexible
layers 403. In some embodiments, the flexible circuit structure 401
includes various electrically conductive layers 404 (three called
out in FIG. 4 as reference symbols 404a, 404b, and 404c). The
electrically conductive layers 404 may be interleaved with the
flexible layers 403. In some embodiments, each of the electrically
conductive layers 404 is patterned to form various electrically
conductive elements. For example, electrically conductive layer
404a may be patterned to form a respective electrode 415 included
as part of each of the transducers 406. Electrodes 415 may have
respective electrode edges 415-1 that form a periphery of an
electrically conductive surface or surface portion associated with
the respective electrode 415.
[0151] In some embodiments, the respective electrically conductive
surface or surface portion of one or more of the electrodes 415 (or
315) is configured to transmit energy to adjacent or contacting
tissue at a level sufficient for ablation of the tissue. Other
energy levels may be transmitted to, for example, provide
stimulation (e.g., electrical stimulation that may include pinging
or pacing) to tissue within a bodily cavity (e.g., left atrium
204), sense characteristics of tissue (e.g., electrophysiological
activity, convective cooling, permittivity, force, temperature,
impedance, thickness, or a combination thereof) within the bodily
cavity, or a combination thereof.
[0152] Electrically conductive layer 404b is patterned, in some
embodiments, to form respective temperature sensors 408 for each of
the transducers 406 as well as various leads 410a arranged to
provide electrical energy to the temperature sensors 408. In some
embodiments, each temperature sensor 408 includes a patterned
resistive element 409 (two called out as 409a and 409b) having a
predetermined electrical resistance. In some embodiments, each
resistive element 409 includes a metal having relatively high
electrical conductivity characteristics (e.g., copper). In some
embodiments, the resistive element 409 has a serpentine form. The
serpentine form has the advantage of providing an increase in the
overall resistance of resistive element 409 by increasing its
overall length while maintaining a compact spatial arrangement. In
some embodiments, each resistive element 409 is connected to an
adjacent resistive element 409 by a conductive element 420 (only
one instance of conductive element 420 is shown in FIG. 4 for
clarity).
[0153] In some embodiments, electrically conductive layer 404c is
patterned to provide portions of various leads 410b arranged to
provide an electrical communication path to electrodes 415. In some
embodiments, leads 410b are arranged to pass though vias (accounted
for in FIG. 4, e.g., by the upward (with respect to the proper
orientation of FIG. 4) movement of the leads 410b) in flexible
layers 403a and 403b to connect with electrodes 415. In various
embodiments, electrically conductive layer 404b, electrically
conductive layer 404c, or both electrically conductive layer 404b
and electrically conductive layer 404c have sufficient length to
allow various ones of leads 410a and 410b (or other leads) to
extend at least outside the body when the transducers 406 are
positioned at desired locations within a bodily cavity comprised by
the body. In various embodiments, electrically conductive layer
404b, electrically conductive layer 404c, or both electrically
conductive layer 404b and electrically conductive layer 404c have
sufficient length to allow at least various ones of leads 410a and
410b (or other leads) to extend across all the particular portions
of an elongate member.
[0154] Although FIG. 4 shows flexible layer 403c as being a
bottom-most layer, some embodiments may include one or more
additional layers underneath flexible layer 403c, such as one or
more structural layers, such as a stainless steel or composite
layer. These one or more structural layers, in some embodiments,
are part of the flexible circuit structure 401 and may be part of,
e.g., elongate member 304. In addition, although FIG. 4 shows only
three flexible layers 403a-403c and only three electrically
conductive layers 404a-404c, it should be noted that other numbers
of flexible layers, other numbers of electrically conductive
layers, or both, may be included. It should be noted that the
various structures of the flexible circuit system, such as the
electrode 415 and resistive element 409, for example, may include
different metals or conductive materials according to some
embodiments.
[0155] It is noted that various elements such as electrodes 415 and
resistive elements 409 are schematically represented in various
orientations that are convenient for the sake of clarity in FIG. 4,
and that at least some of these orientations may be different from
one another. It is also noted that various elements are not shown
to scale. For example, according to some embodiments, while layers
403a, 403b and 403c may be considered to be depicted by side
elevation views of the layers on FIG. 4, electrodes 415 and
resistive elements 409 may be considered to be depicted by
perspective or plan views of the particular layers they are formed
from. It is understood that these different orientations are
provided to facilitate the discussion of these various elements and
do not impose a limitation on the spatial or structural
arrangements.
[0156] In some embodiments, the flexible circuit structure 401 may
include at least one electrically nonconductive flexible layer 403
(electrically nonconductive substrate), at least one electrically
conductive flexible circuit layer 404 coupled, directly or
indirectly, to the at least one electrically nonconductive flexible
layer 403. In some embodiments, the electrically conductive
flexible circuit layer 404 may include conductive patterns
including the plurality of resistive elements 409.
[0157] In some embodiments, the flexible circuit structure 401 is
electrically connected to a voltage or current measurement system
(e.g., provided at least in part by (a) input-output device system
120, 320, (b) data processing device system 110, 310, or both (a)
and (b), by the plurality of measurement leads 410a. In some
embodiments, respective pairs of measurement leads 410a are
arranged to sense voltage or current across each resistive element
409. In some embodiments, at least some of the measurement leads
410a are electrically connected to a respective conductive element
420. In some embodiments, voltage measurement leads 410a are
arranged to allow for a sampling of electrical voltage between each
resistive element 409. These arrangements allow for the electrical
resistance of each resistive element 409 to be accurately
determined. The ability to accurately determine the electrical
resistance of each resistive element 409 may be motivated by
various reasons including determining temperature values at
locations at least proximate the resistive element 409 based at
least on changes in the resistance caused by convective cooling
effects (e.g., as provided by blood flow).
[0158] In some embodiments, electrodes 415 are employed to
selectively deliver RF energy to various tissue structures within a
bodily cavity (not shown) (e.g., a tissue cavity such as an
intra-cardiac cavity). The energy delivered to the tissue
structures may be sufficient for ablating portions of the tissue
structures. In various embodiments, the tissue structures are
typically formed from non-fluidic tissue and the energy sufficient
for ablating portions of the tissue structures is typically
referred to as sufficient for tissue ablation. It is noted that
energy sufficient for non-fluidic-tissue ablation may include
energy levels sufficient to disrupt or alter fluidic tissue (e.g.,
blood) that may, for example, be located proximate the tissue
structure. In many cases, the application of
non-fluidic-tissue-ablative energy (i.e., energy that is sufficient
to ablate non-fluidic tissue) to fluidic tissue, such as blood, is
undesired when the energy is sufficient to disrupt or adversely
impact a property of the fluidic tissue. For example, the
application of non-fluidic-tissue-ablative energy to blood may be
undesired when the energy is sufficient to cause various parts of
the blood to coagulate in a process typically referred to as
thermal coagulation. In this regard, some embodiments facilitate
detection of conditions where an electrode configured to deliver
non-fluidic-tissue-ablative energy may be in a configuration where
it is not able to properly transmit such energy. In some
embodiments, a detection of such a condition results in an error
notification being transmitted or otherwise presented to a user or,
in some embodiments, a restriction of that electrode from
transmitting at least a portion of the non-fluidic-tissue-ablative
energy. In some embodiments, a detection of such a condition
results in an error notification being transmitted or otherwise
presented to a user or, in some embodiments, a restriction of that
electrode from being selected by a user action (e.g., a user
selection of that electrode from a number of selectable electrodes
to perform a particular function, such as transmitting at least a
portion of the non-fluidic-tissue-ablative energy).
[0159] The energy delivered to the tissue may be delivered to cause
monopolar tissue ablation, bipolar tissue ablation, or blended
monopolar-bipolar tissue ablation by way of non-limiting example.
In some embodiments, each electrode 415 is employed to sense an
electrical potential in the tissue proximate the electrode 415. In
some embodiments, each electrode 415 is employed in the generation
of an intra-cardiac electrogram. In some embodiments, each
resistive element 409 is positioned adjacent a respective one of
the electrodes 415. In some embodiments, each of the resistive
elements 409 is positioned in a stacked or layered array with a
respective one of the electrodes 415 to form a respective one of
the transducers 406. In some embodiments, the resistive elements
409 are connected in series to allow electrical current to pass
through all of the resistive elements 409. In some embodiments,
leads 410a are arranged to allow for a sampling of electrical
voltage across each resistive element 409. This arrangement allows
for the electrical resistance of each resistive element 409 to be
accurately determined. The ability to accurately determine the
electrical resistance of each resistive element 409 may be
motivated by various reasons including determining temperature
values at locations at least proximate the resistive element 409
based at least on changes in the resistance caused by convective
cooling effects (e.g., as provided by blood flow). In various
embodiments, some of the transducers 406 are controlled to provide
one or more electrical signals to tissue (e.g., non-fluidic tissue
associated with a tissue wall or fluidic tissue such as blood) and
information or a derivative thereof is determined in response to
the provided signals, the information or the derivative thereof
indicating a result of an interaction between the one or more
signals and the tissue. In various ones of these embodiments, the
one or more signals may include one or more energy levels
insufficient for tissue ablation.
[0160] In some embodiments in which the electrode-based device
system 300 is deployed in a bodily cavity (e.g., when the
electrode-based device system 300 takes the form of a catheter
device system arranged to be percutaneously or intravascularly
delivered to a bodily cavity), it may be desirable to perform
various mapping procedures in the bodily cavity. For example, when
the bodily cavity is an intra-cardiac cavity, a desired mapping
procedure may include mapping electrophysiological activity in the
intra-cardiac cavity. Other desired mapping procedures may include
mapping of various anatomical features within a bodily cavity. An
example of the mapping performed by devices according to various
embodiments may include locating the position of the ports of
various bodily openings positioned in fluid communication with a
bodily cavity. For example, in some embodiments, it may be desired
to determine the locations of various ones of the pulmonary veins
or the mitral valve that each interrupts an interior surface of an
intra-cardiac cavity such as a left atrium.
[0161] In some example embodiments, the mapping is based at least
on locating bodily openings by differentiating between fluid and
non-fluidic tissue (e.g., tissue defining a surface of a bodily
cavity). There are many ways to differentiate non-fluidic tissue
from a fluid such as blood or to differentiate tissue from a bodily
opening in case a fluid is not present. Four approaches may include
by way of non-limiting example, and, depending upon the particular
approach(es) chosen, the configuration of transducers 406 in FIG. 4
may be implemented accordingly:
[0162] 1. The use of convective cooling of heated transducer
elements by fluid. An arrangement of slightly heated transducer
elements that is positioned adjacent the tissue that forms the
interior surface(s) of a bodily cavity and across the ports of the
bodily cavity will be cooler at the areas which are spanning the
ports carrying the flow of fluid.
[0163] 2. The use of tissue impedance measurements. A set of
transducers positioned adjacently to tissue that forms the interior
surface(s) of a bodily cavity and across the ports of the bodily
cavity may be responsive to electrical tissue impedance. Typically,
heart tissue will have higher associated tissue impedance values
than the impedance values associated with blood.
[0164] 3. The use of a differing change in dielectric constant as a
function of frequency between blood and tissue. A set of
transducers positioned around the tissue that forms the interior
surface(s) of the atrium and across the ports of the atrium
monitors the ratio of the dielectric constant from 1 kHz to 100
kHz. Such may be used to determine which of those transducers is
not proximate tissue, which is indicative of the locations of the
ports.
[0165] 4. The use of transducers that sense force (i.e., force
sensors). A set of force detection transducers positioned around
the tissue that forms the interior surface(s) of a bodily cavity
and across the bodily openings or ports of the bodily cavity may be
used to determine which of the transducers are not engaged with the
tissue, which may be indicative of the locations of the ports.
[0166] Various ones of the above approaches may be used, at least
in part, to determine proximity of a transducer to non-fluidic
tissue or to fluidic tissue in some embodiments. Various ones of
the above approaches may be used, at least in part, to determine
contact between a transducer and non-fluidic tissue or contact
between a transducer and fluidic tissue in some embodiments.
Various ones of the above approaches may be used, at least in part,
to determine an amount of an electrically conductive surface
portion of an electrode that contacts non-fluidic tissue or
contacts fluidic tissue in some embodiments. Various ones of the
above approaches may be used, at least in part, to determine an
amount of an electrically conductive surface portion of an
electrode that is available to contact non-fluidic tissue or
available to contact fluidic tissue in some embodiments.
[0167] Referring again to the medical device systems of FIGS. 3A
and 3B, according to some embodiments, electrode-based device
system 300 communicates with, receives power from or is controlled
by a transducer-activation system 322, which may include a
controller 324 and an energy source device system 340. In some
embodiments, the controller 324 includes a data processing device
system 310 and a memory device system 330 that stores data and
instructions that are executable by the data processing device
system 310 to process information received from other components of
the medical device system of FIGS. 3A and 3B or to control
operation of components of the medical device system of FIGS. 3A
and 3B, for example by activating various selected transducers 306
to ablate tissue, sense tissue characteristics, et cetera. In this
regard, the data processing device system 310 may correspond to at
least part of the data processing device system 110 in FIG. 1,
according to some embodiments, and the memory device system 330 may
correspond to at least part of the memory device system 130 in FIG.
1, according to some embodiments. The energy source device system
340, in some embodiments, is part of an input-output device system
320, which may correspond to at least part of the input-output
device system 120 in FIG. 1. Although only a single controller 324
is illustrated, it should be noted that such controller 324 may be
implemented by a plurality of controllers. In some embodiments, the
electrode-based device system 300 is considered to be part of the
input-output device system 320. The input-output device system 320
may also include a display device system 332, a speaker device
system 334, or any other device such as those described above with
respect to the input-output device system 120.
[0168] In some embodiments, particular portions (e.g., 309, where
309a, 309b are shown in FIGS. 3A and 3B, and 309c is shown in at
least FIGS. 3G and 3H) of the elongate members 304 may include or
form at least a portion or an extension of control leads 317 that
reside, at least in part (e.g., portion 309c), in the shaft member
316 and, at least in part, in the flexible catheter 314. For
example, the leads 410a, 410b in FIG. 4 may be or form a portion or
an extension of control leads 317 in some embodiments. The control
leads may be connected to the controller 324 at a connector 321 or
other interface with the transducer-activation system 322 and
provide communication pathways between at least the transducers 306
and the controller 324, according to some embodiments. In some
embodiments in which particular portions of the elongate members
304 may include, or form a portion or an extension of, control
leads 317, various particular portions of the elongate members 304
may be provided by flexible circuit structures (e.g., 401). In some
embodiments, the elongate members 304 may terminate at connector
321 or other interface with the transducer-activation system 322,
e.g., at the controller 324 or data processing device system 310,
and provide communication pathways between at least the transducers
306 and the controller 324. In some embodiments, in which
particular portions of the elongate members 304 may include or form
a portion or an extension of control leads 317, the elongate
members may terminate at or in a housing physically coupled to
shaft member 316, such as a housing of controller 324 or other
housing (e.g. a housing provided as part of handle portion as
described in U.S. Pat. No. 9,452,016, issued Sep. 27, 2016, which
is hereby incorporated herein by reference in its entirety.
[0169] As discussed with respect to FIG. 4, each of various ones of
the transducers 306, 406 includes an electrode 315, 415, according
to some embodiments. In these various embodiments, each of at least
some of the electrodes 315, 415 may include a respective energy
transmission surface (e.g., energy transmission surface 319 in FIG.
3A) configured to transfer, transmit, or deliver energy, for
example, to tissue. In some embodiments, at least some of the
respective energy transmission surfaces 319 are configured to
receive energy, for example, from tissue. Each of the energy
transmission surfaces may be bound by a respective electrode edge
315-1 (e.g., FIG. 3A), 415-1 (e.g., FIG. 4).
[0170] In various embodiments, each of the electrodes 315 includes
an electrically conductive surface portion (e.g., energy
transmission surface 319) that, in some embodiments, has an
electrical conductivity that is typically greater than that of
fluidic and non-fluidic tissue. In some embodiments, the entirety
of the electrically conductive surface portion is configured to
contact or is configured to be available or exposed for contact
with a contiguous portion of a non-fluidic tissue surface (e.g., a
tissue surface that defines a tissue wall). Complete contact
between the entirety of the electrically conductive surface portion
and the non-fluidic tissue may be motivated for different reasons.
For example, various desired characteristics required in a lesion
formed in a tissue wall in a tissue ablation procedure may be
dependent on the degree of intimate contact established between the
electrically conductive surface portion of the electrode 315 and
the tissue wall. For example, intimate contact may be required to
form a lesion having sufficient transmurality to act as an
effective electrophysiological activity block (e.g., a block
capable of forming a barrier to spurious electrical signals causing
fibrillation in an atrium). In some cases, complete contact between
the entirety of the electrically conductive surface portion and the
non-fluidic tissue may be desired to reduce the time required to
form a lesion to a desired tissue depth under the influence of a
given ablation energy level. In some cases, complete contact
between the entirety of the electrically conductive surface portion
of the electrode 315 and the non-fluidic tissue may be desired to
reduce transmission of ablative energy to a surrounding fluidic
tissue. In some cases, complete contact between the entirety of the
electrically conductive surface portion of the electrode 315 and
the non-fluidic tissue may be desired to reduce or eliminate
exposure of the electrically conductive surface portion of the
electrode 315 to surrounding fluidic tissue when the electrically
conductive surface portion of the electrode 315 is positioned in
contact with non-fluidic tissue. In some embodiments, the entirety
of the portion of the electrically conductive surface of the
electrode 315 that is configured to contact or is configured to be
available or exposed (e.g., without some obstruction preventing at
least some of the ability) to contact a tissue wall surface
includes all of the electrically conductive surface. For example,
this may occur when the electrically conductive surface has a
generally planar form (e.g., a generally planar conductive surface
provided by an electrode formed by flexible circuit fabrication
techniques (e.g., electrode 415)). In some embodiments, the
entirety of the portion of the electrically conductive surface of
the electrode that is configured to contact or is configured to be
available or exposed to contact a tissue wall surface includes
some, but not all, of the electrically conductive surface. For
example, this may occur when the electrode has a generally
three-dimensional surface (e.g., a surface having a cylindrical,
hemi-spherical or other three-dimensional form) with only a portion
less than the entirety of the three-dimensional surface configured
to contact or configured to be available or exposed for contact
with a tissue surface wall.
[0171] In some embodiments, input-output device system 320 may
include a sensing device system 325 configured to detect various
characteristics or conditions including, but not limited to, at
least one of tissue characteristics (e.g., electrical
characteristics such as tissue impedance, tissue type, tissue
thickness) and thermal characteristics such as temperature. Various
other particular conditions may be detected by sensing device
system 325 according to various embodiments. It is noted that in
some embodiments, sensing device system 325 includes various
sensing devices or transducers configured to sense or detect a
particular condition while positioned within a bodily cavity. In
some embodiments, at least part of the sensing device system 325
may be provided by electrode-based device system 300 (e.g., various
ones of transducers 306). In some embodiments, sensing device
system 325 includes various sensing devices or transducers
configured to sense or detect a particular condition while
positioned outside a given bodily cavity or even outside a body
that includes the bodily cavity. In some embodiments, the sensing
device system 325 may include an ultrasound device system or a
fluoroscopy device system or portions thereof by way of
non-limiting example.
[0172] The energy source device system 340 may, for example, be
connected to various selected transducers 306 or their respective
electrodes 315 to provide energy in the form of electrical current
or energy (e.g., RF energy) to the various selected transducers 306
or their respective electrodes 315 to cause ablation of tissue. In
this regard, although FIGS. 3A and 3B show a communicative
connection between the energy source device system 340 and the
controller 324 (and its data processing device system 310), the
energy source device system 340 may also be connected to the
transducers 306 or their respective electrodes 315 via a
communicative connection that is independent of the communicative
connection with the controller 324 (and its data processing device
system 310). For example, the energy source device system 340 may
receive control signals via the communicative connection with the
controller 324 (and its data processing device system 310), and, in
response to such control signals, deliver energy to, receive energy
from, or both deliver energy to and receive energy from one or more
of the transducers 306 via a communicative connection with such
transducers 306 or their respective electrodes 315 (e.g., via one
or more communication lines through catheter 314, shaft member 316
or catheter sheath 312) that does not pass through the controller
324. In this regard, the energy source device system 340 may
provide results of its delivering energy to, receiving energy from,
or both delivering energy to and receiving energy from one or more
of the transducers 306 or the respective electrodes 315 to the
controller 324 (and its data processing device system 310) via the
communicative connection between the energy source device system
340 and the controller 324.
[0173] The energy source device system 340 may, for example,
provide energy in the form of electrical current to various
selected transducers 306 or their respective electrodes 315.
Determination of a temperature characteristic, an electrical
characteristic, or both, at a respective location at least
proximate each of the various transducers 306 or their respective
electrodes 315 may be made under the influence of energy or current
provided by the energy source device system 340 in various
embodiments. Energy provided to an electrode 315 by the energy
source device system 340 may in turn be transmittable by the
electrodes 315 to adjacent tissue (e.g., tissue forming a tissue
wall surface). In various embodiments, the transmittable energy is
sufficient for tissue ablation. In some embodiments, the energy is
insufficient for tissue ablation. The energy source device system
340 may include various electrical current sources or electrical
power sources. In some embodiments, an indifferent electrode 326 is
provided to receive at least a portion of the energy transmitted by
at least some of the transducers 306 or their respective electrodes
315. Consequently, although not shown in FIGS. 3A and 3B, the
indifferent electrode may be communicatively connected to the
energy source device system 340 via one or more communication lines
in some embodiments. The indifferent electrode 326 is typically
configured to be positioned outside of a bodily cavity and may be
positioned on an exterior body surface and, in some embodiments,
although shown separately in FIGS. 3A and 3B, is considered part of
and communicatively connected to the energy source device system
340.
[0174] Structure 308 may be delivered and retrieved at least in
part via a catheter member, for example, a catheter sheath 312
(shown in FIG. 3A). It is noted according to some embodiments that
structure 308 is typically deliverable or retrievable (e.g., in an
unexpanded or delivery configuration) through a lumen of catheter
sheath 312 by way of translation of at least part of the shaft
member 316 through the lumen of the catheter sheath 312. In this
regard, it may be understood that the structure 308 and the
associated elongate members 304 are not coupled to catheter sheath
312 at a location that is fixed with respect to a reference
location on the catheter sheath 312 (e.g., a distal end of the
catheter sheath) since the structure 308 and associated elongate
members 304 are free to translate through the catheter sheath
312.
[0175] In some embodiments, the structure 308 provides expansion
and contraction capabilities for a portion of a medical device
(e.g., an arrangement, distribution or array of transducers 306).
The transducers 306 may form part of, be positioned or located on,
mounted or otherwise carried on the structure 308 and the structure
308 may be configurable to be appropriately sized to slide within
catheter sheath 312 in order to be deployed percutaneously or
intravascularly. FIG. 3A shows one embodiment of such a structure
308, where particular portions of the elongate members 304 (e.g.,
first portions or (e.g., also referred to as) first particular
portions 309a that may be included in and collectively form
structure 308), in some embodiments, are stacked in a stacked
arrangement (which may provide an example of what is sometimes
referred to herein as a second stacked arrangement) in the delivery
or unexpanded configuration to facilitate fitting within the
flexible catheter sheath 312 or to facilitate percutaneous or
intravascular delivery of structure 308 to a bodily cavity. FIG. 3B
shows an embodiment of structure 308 in an expanded or deployed
configuration in which structure 308 has or an arrangement of first
particular portions 309a of elongate members 304 have enlarged or
expanded to a size unsuitable to facilitate fitting with the
catheter sheath 312 or unsuitable to facilitate percutaneous or
intravascular delivery of structure 308 to a bodily cavity.
[0176] In some embodiments, each of the elongate members 304
includes a respective distal or second end 305 (only one called out
in each of FIGS. 3A and 3B), a respective proximal or first end
(e.g., 307, only one called out in each of FIGS. 3A and 3B), and a
plurality of particular portions 309 positioned or arranged between
the proximal end (e.g., 307) and the distal end 305. Various
particular portions 309 are described in greater detail below. In
some embodiments, each particular elongate member 304 includes a
length extending along the elongate member 304 from the respective
distal or second end 305 to the respective proximal or first end
(e.g., 307) of the particular elongate member 304. In some
embodiments, at least one particular portion 309 of each respective
elongate member 304 may be located at a location where the
structure 308 is coupled to the distal portion (e.g., a portion at
least adjacent distal end 316b) of the shaft member 316. In some
embodiments, at least a first particular portion 309 (e.g., first
particular portion 309a bearing transducers 306) of each elongate
member 304 extends outwardly from the shaft distal end 316b of the
shaft member 316. In some embodiments, at least a first particular
portion 309 (e.g., first particular portion 309a including
transducers 306) of each elongate member 304 extends outwardly from
the shaft distal end 316b of the shaft member 316, while
concurrently, other particular portions 309 (e.g., second portions
or second particular portions 309c) of the elongate member reside
or are located within the elongated portion 316c of the shaft
member 316 (e.g., as described in more detail below). In some
embodiments, at least a second particular portion (e.g., second
particular portion 309c) of each elongate member resides or is
located within the elongated portion 316c of the shaft member 316
(e.g., as described in more detail below).
[0177] The plurality of portions 309 of each particular elongate
member 304 provide at least the respective portions 309a (e.g.,
FIGS. 3A, 3B, 3G, 3H, 3K, 3L), 309b (e.g., FIGS. 3A, 3B, 3G, 3H,
3K, 3L), 309c (e.g., FIGS. 3G, 3H, 3K, 3L), and other portions
described herein, according to some embodiments. In some
embodiments, the plurality of portions 309 of each particular
elongate member 304 collectively provide a first or front surface
or side 318a of the particular elongate member 304, the first or
front surface or side 318a positionable to face away from an
interior of the bodily cavity toward an interior tissue surface
within the bodily cavity (e.g., FIGS. 2A, 2B). In some embodiments,
the plurality of portions 309 of each particular elongate member
304 collectively provide a second or back surface or side 318b
opposite across a thickness 327 of the particular elongate member
304 from the front surface or side 318a of the particular elongate
member 304. In some embodiments, at least a portion of the front
surface or side 318a of each particular elongate member 304 faces
outwardly from an interior of the structure 308 when the structure
308 is in the deployed or expanded configuration (e.g., as shown in
FIGS. 2A, 2B, 3B, 3C). A width 323 (e.g., FIG. 3B) of each
respective elongate member 304 is perpendicular to and longer than
the thickness 327 and perpendicular to the length of the respective
elongate member 304, according to some embodiments. In the expanded
or deployed configuration, it may be considered, according to some
embodiments, that the width 323 of a respective elongate member 304
at a particular location along the elongate member 304 is
perpendicular to a tangent of the length of the respective elongate
member 304 at the particular location, since the respective
elongate member 304 may exhibit curvature.
[0178] In some embodiments, at least part of the front surface 318a
of each elongate member 304 is an outward-facing surface portion,
each outward-facing surface portion positionable to face away from
an interior of the bodily cavity and an interior of the structure
308 toward a tissue surface of a wall of the bodily cavity in a
state in which the structure 308 is positioned in the bodily cavity
in an expanded or deployed configuration (e.g., FIGS. 2A, 2B).
Similarly, in some embodiments, all or part of the back surface
318b of each elongate member 304 is an inward-facing surface
portion opposite the respective outward-facing surface portion,
each inward-facing surface portion positionable to face toward an
interior of the bodily cavity and an interior of the structure 308
in the state in which the structure 308 is positioned in the bodily
cavity in an expanded or deployed configuration (e.g., FIGS. 2A,
2B).
[0179] In some embodiments, all or part of the front surface 318a
of each elongate member 304 is an outward-facing surface portion,
each outward-facing surface portion positionable to face outwardly
or away from an interior of the structure 308 when the structure
308 is an expanded or deployed configuration (e.g., FIGS. 2A, 2B,
3B, 3C). Similarly, in some embodiments, all or part of the back
surface 318b of each elongate member 304 is an inward-facing
surface portion opposite the respective outward-facing surface
portion, each inward-facing surface portion positionable to face
toward an interior of the structure 308 when the structure 308 is
in an expanded or deployed configuration. In various embodiments,
the various particular portions 309 of each particular elongate
member 304 of the particular elongate member 304 collectively
provide the front surface 318a, the back surface 318b, or both the
front surface 318a and the back surface 318b of the particular
elongate member 304.
[0180] In some embodiments, each elongate member 304 includes a
non-helical twisted portion 345 (only one called out in each of
FIGS. 3A and 3B) at a location proximate at least the respective
first particular portion 309a or at least proximate shaft distal
end 316b of shaft member 316. The non-helical twisted portions 345
are located outside of the shaft member 316, beyond the shaft
distal end 316b, when the structure 308 is in the expanded or
deployed configuration (e.g., FIGS. 2A, 2B, 3B, 3C) and also when
the structure 308 is in the unexpanded or delivery configuration
(e.g., FIG. 3A). According to some embodiments, various particular
portions (e.g., first particular portions 309a) of the elongate
members 304 in the expanded or deployed configuration (e.g., FIGS.
2A, 2B, 3B, 3C) are fanned as compared to their corresponding
positions in the unexpanded or delivery configuration (e.g., FIG.
3A). In some embodiments, various portions of the elongate members
304, such as non-helical twisted portions 345, may assist in or
facilitate fanning of the elongate members 304 when the structure
308 moves from the delivery configuration (e.g., FIG. 3A) to the
expanded or deployed configuration (e.g., FIGS. 2A, 2B, 3B, 3C). In
various embodiments, each twisted portion 345 assumes a twisted and
non-helical configuration that includes only about a quarter turn
of rotation (approximately 90 degrees in some embodiments, less
than 110 degrees in some embodiments, or less than 90 degrees in
some embodiments). This relatively small amount of twist in
portions 345 allows the first particular portions 309a to be
oriented with their front surfaces 318a facing outwardly from an
interior of the structure 308 when the structure 308 is in the
expanded or deployed configuration. Alternatively or additionally,
the relatively small amount of twist in portions 345 may facilitate
a movement of the first particular portions 309a during a movement
from the unexpanded or delivery configuration to the expanded or
deployed configuration by allowing the portions 309b to be oriented
in a favorable orientation to provide at least part of the fanning
action. That is, while first particular portions 309a may be too
stiff to adequately bend in the direction of fanning (e.g., across
their width 323) in some embodiments, portions 309b are oriented by
the non-helical twisted portion 345 in their preferred bending
orientation (e.g., across their thickness 327) to at least in part
provide the required fanning action, according to some embodiments.
It is noted that portions 309b may be pre-formed to bend outwardly
when portions 309b are advanced outwardly from the confines of the
catheter sheath 312 to provide some degree of autonomous fanning
capability to the first particular portions 309a, for example, as
described in U.S. Pat. No. 9,492,227, issued Nov. 15, 2016, which
is hereby incorporated herein by reference in its entirety.
According to various embodiments, each of the non-helical twisted
portions 345 may twist along a same rotational direction when
structure 308 is in the unexpanded or delivery configuration, the
same rotational direction being a same clockwise direction or a
same counterclockwise direction. In various embodiments, the
non-helical twisted portions 345 of the elongate members 304 are
arranged in a collective non-helical twisted configuration when the
structure 308 is in the unexpanded or delivery configuration.
[0181] In some embodiments, at least various ones of the elongate
members 304 may include various particular portions in which a
twist or twisted region is absent or substantially absent when the
structure 308 is at least in the delivery configuration shown, for
example, in FIG. 3A. In other words, while a non-helical twisting
portion 345 may exist at an external location beyond shaft distal
end 316b of shaft member 316 (e.g., to assist deployment of the
structure 308 from the delivery or unexpanded configuration (e.g.,
FIG. 3A) to the expanded or deployed configuration (e.g., at least
FIG. 3B)), other particular portions 309 (e.g., first particular
portion 309a) may be free or substantially free of any twist,
according to some embodiments. In some embodiments, at least one
portion 309 (e.g., first particular portion 309a) of each elongate
member 304 is not arranged in a twisted configuration at least (a)
when the structure 308 is in the unexpanded or delivery
configuration, (b) when the structure 308 is in the expanded or
deployed configuration, or both (a) and (b), as shown, e.g., in at
least FIGS. 3A and 3B. Each of the phrases "substantially absent"
and "substantially free" in this context means less than 15 degrees
of twist in some embodiments, or less than ten degrees, five
degrees, or two degrees in other embodiments. It should be noted
that each of the terms "absent" and "free" in this context means
less than two degrees or less than one degree, according to some
embodiments.
[0182] As shown in FIG. 3A, according to some embodiments,
particular portions (e.g., first particular portions 309a) of the
elongate members 304 are arranged successively with respect to one
another in a stacked arrangement (which may provide an example of
what is sometimes referred to herein as a second stacked
arrangement) when the structure 308 is in an unexpanded or delivery
configuration. In various embodiments, the arrangement of the
portions of the elongate members 304 in the stacked arrangement is
an orderly one with each of the elongate members 304 arranged
successively with respect to one another along a first direction
(e.g., a stacking direction) represented by arrow 338a. It is
understood that the first direction need not be a vertical or
"up-down" direction but can also include other orientations. For
instance, in some embodiments, various portions of elongate members
304, which are successively adjacent one another along the first
direction 338a, may be stepped with respect to one another in one
or more other directions. Thus, the set of elongate members 304 may
be arranged in a non-stepped stacked arrangement fitting in a
rectangular parallelepiped or may be arranged in a stepped stacked
arrangement, for instance, fitting in a non-rectangular
parallelepiped. As shown in FIG. 3A, according to some embodiments,
particular portions (e.g., first particular portions 309a) of at
least a set (which may provide an example of what is sometimes
referred to herein as a second set) of at least three of the
plurality of elongate members 304 are arranged front surface (e.g.,
318a)-toward-back surface (e.g., 318b) in a stacked arrangement
(which may provide an example of what is sometimes referred to
herein as a second stacked arrangement) when the structure 308 is
in a delivery or unexpanded configuration. According to some
embodiments, each of the elongate members 304 is a strip-like
member. According to some embodiments, each of the elongate members
304 is a planar member. Planar members may include at least one
surface that is flat or generally flat, according to some
embodiments. It is noted, according to some embodiments, that a
planar member need not be flat (i.e., in two orthogonal directions)
in all states or configurations. For example, a member including at
least a flattened surface may be sufficiently flexible to impart
some amount of curvature to the member and its flattened surface.
Such a member is still considered to be, according to various
embodiments, a planar member, since the flexibility of the member
allows it to be bent into form in which the flattened surface may
conform at least generally to a plane. According to some
embodiments, each of the elongate members 304 is a non-planar
member. For example, according to some embodiments, a non-planar
member includes a member that does not include at least one
flattened or planar surface or a member which does not have
flexibility to be elastically manipulated (e.g., by bending) to
include at least one flattened or planar surface.
[0183] In various embodiments, various portions of the elongate
members 304 are successively arranged in an arrayed or stacked
arrangement sized to be delivered through a lumen of catheter
sheath 312, with each elongate member 304 positioned in the arrayed
or stacked arrangement, such that the first surface 318a of the
elongate member 304 is toward the second surface 318b of a first
additional elongate member 304 in the arrayed or stacked
arrangement, or the second surface 318b of the elongate member 304
is toward the first surface 318a of a second additional elongate
member 304 in the arrayed or stacked arrangement, or both. For
example, one of the outermost elongate members 304 in the arrayed
or stacked arrangement is positioned in the arrayed or stacked
arrangement such that its first surface 318a is toward the second
surface 318b of another elongate member 304. Another of the
outermost elongate member 304 is positioned in the arrayed or
stacked arrangement such that its second surface 318b is toward the
first surface 318a of another elongate member 304. An inboard
elongate member 304 in the arrayed or stacked arrangement is
positioned such that its first surface 318a is positioned toward
the second surface 318b (not called out) of another elongate member
304 and the second surface 318b of inboard elongate member 304 is
toward the first surface 318a of yet another elongate member 304.
In some example embodiments, the first and the second surfaces
318a, 318b of the elongate members 304 are interleaved in the
arrayed or stacked arrangement.
[0184] In various embodiments, each of the elongate members 304 has
at least one surface that has a common characteristic with, or
corresponds to, at least one surface of each of the other elongate
members 304, and the elongate members 304 are arranged in an
arrayed arrangement or stacked arrangement such that respective
portions of the at least one surfaces of the elongate members 304
are successively arranged along the first direction of the stacked
arrangement. In this respect, it is noted that the stacked
arrangement does not require that the individual elongate members
304 actually rest on one another. In many instances of the stacked
arrangement, the elongate members 304 or portions thereof may be
separated from successively adjacent elongate members 304, or
portions thereof for instance by space, such as in an embodiment of
an interleaved arrangement. In some of these various embodiments,
each at least one surface is a first surface, at least part thereof
positionable adjacent, or proximate a tissue surface in the bodily
cavity when the structure 308 is in the expanded or deployed
configuration within the bodily cavity. In some of these various
embodiments, each of at least the one surface is a first surface
with a portion thereof that is positionable to face or contact a
tissue surface in the bodily cavity when the structure 308 is in an
expanded or deployed configuration within a bodily cavity. In some
of these various embodiments, each at least one surface is a first
surface that includes, or supports (i.e., directly or indirectly)
one or more transducer elements. In some of these various
embodiments, each at least one surface includes a first surface
that includes, or supports (i.e., directly or indirectly) one or
more transducer elements (e.g., an electrode) that are positionable
adjacent a tissue surface in the bodily cavity when the structure
308 is in an expanded or deployed configuration within the bodily
cavity. In some of these various embodiments, each at least one
surface includes a first surface that includes, or supports (i.e.,
directly or indirectly) at least part of a flexible circuit
structure. In some of these various embodiments, each at least one
surface is a second surface with a portion thereof that is
positionable to face away from a tissue surface in the bodily
cavity when the structure 308 is in an expanded or deployed
configuration within the bodily cavity. In some of these various
embodiments, a respective portion of each at least one surface is
arranged to face outwardly away from an interior or interior space
of the structure 308 when the structure 308 is in an expanded or
deployed configuration.
[0185] In some embodiments, various portions of the elongate
members 304 are arranged successively adjacent one another when the
structure 308 is in an unexpanded or delivery configuration. In
some embodiments, various particular portions of the elongate
members 304 face (and, in some embodiments, contact) each other
when the structure 308 is in an unexpanded or delivery
configuration. For example, a particular portion (e.g., a facing or
contacting portion) of the front surface 318a of a first elongate
member 304 may face (and, in some embodiments, contact) a
particular portion (e.g., a facing or contacting portion) of the
back surface 318b of a second elongate member 304 when the
structure 308 is in an unexpanded or delivery configuration. In
some embodiments, the respective portions (e.g., facing or
contacting portions) of the first elongate member 304 and the
second elongate member 304 are provided at least in part by
respective ones of the first particular portions 309a of the first
and the second elongate members 304. In some embodiments, at least
the facing or contacting portion of the front surface 318a of the
first elongate member 304 follows a contour of at least the facing
or contacting portion of the back surface 318b of the second
elongate member 304 when the structure is in an unexpanded or
delivery configuration. For example, in the unexpanded or delivery
configuration shown in FIG. 3A according to some embodiments, the
first particular portions 309a of the elongate members 304 face
(and, in some embodiments contact) each other in a front
surface-toward-back surface manner and the contour of the front
surface 318a of at least one of the elongate members 304 follows
the contour of the back surface 318b of another of the elongate
members 304.
[0186] In some embodiments, the respective facing or contacting
portions of the first elongate member 304 and the second elongate
member 304 are arranged front surface-toward-back surface as part
of stacked arrangement when the structure 308 is in an unexpanded
or delivery configuration. Depending on the degree of compacting of
the elongate members in the stacked arrangement, partial or full
separations or gaps can be present between two elongate members 304
of various ones of the successive pairs of elongate members 304 in
the stacked arrangement (e.g., when the structure 308 is in an
unexpanded or delivery configuration). Substantially uniform or
non-uniform separations or varying sized separations between the
two elongate members 304 of each successive pair of the elongate
members 304 in the stacked arrangement can be present. In some
example embodiments, various other elements may be disposed between
two elongate members 304 of various ones of the successive pairs of
the elongate members 304 in the stacked arrangement. For example,
various transducer elements may be positioned between two elongate
members 304 of various ones of the successive pairs of the elongate
members 304 in the stacked arrangement. Various particular portions
(e.g., first particular portions 309a) of the elongate members 304
can be linearly arrayed along the first direction (i.e., as
represented by arrow 338a) in the stacked arrangement. In some
embodiments, various particular portions (e.g., first particular
portions 309a) of at least three elongate members 304 are linearly
arrayed along a first direction (e.g., as represented by arrow
338a) in an arrayed arrangement when the structure is in the
unexpanded or delivery configuration. In some embodiments, various
particular portions (e.g., first particular portions 309a) of at
least three elongate members 304 are successively arranged with
respect to one another along a first direction (e.g., as
represented by arrow 338a) in a stacked arrangement when the
structure is in the unexpanded or delivery configuration. In some
embodiments, various particular portions (e.g., first particular
portions 309a) of at least three elongate members 304 are arranged
front surface-toward-back surface in a stacked arrangement when the
structure is in the unexpanded or delivery configuration.
[0187] Various particular portions of elongate members 304 (e.g.,
first particular portions 309a) may be substantially planar in form
with or without some degree of curvature (e.g., curvature imparted
by bending) (a) when the structure 308 is in the unexpanded or
delivery configuration, (b) when the structure 308 is in the
expanded or deployed configuration, or both (a) and (b). At least
one of surfaces 318a and 318b need not be a flat surface. For
example, at least one of surfaces 318a and 318b may include a
convex or concave surface portion (e.g., across width 323)
according to some embodiments. In embodiments where the electrodes
315 are considered part of their respective elongate members, the
energy transmission surfaces 319 of such electrodes 315 may
respectively represent an elevated surface portion of the
respective front surface 318a of the respective elongate member
304, which is an example of a non-flat surface. However, in some
embodiments, the energy transmission surfaces 319 may be flush
(e.g., flush to the touch) with other surface portions of the
respective elongate member 304, at least in some embodiments where
the respective front surface 318a of the respective elongate member
304 is flat. In some example embodiments, various portions of the
elongate members 304 have a shape that allows them to be
successively stacked in a stacked arrangement. Stacked arrangements
advantageously allow elongate members 304 to be arranged in a
substantially spatially efficient manner to allow for delivery
through bodily openings or catheter sheaths, thereby enabling
reduced cross-sectional dimensions.
[0188] Advantageously, stacked portions of elongate members 304
allow for reduced bending stiffness about a bending axis arranged
perpendicularly to the first or stacking direction of the portions
of the elongate members 304 in stacked arrangement, especially when
the portions of the elongate members are allowed to slide
relatively with respect to one another during the bending. A
reduced bending stiffness can facilitate the delivery of the
stacked arrangement through catheter sheath 312 especially when
catheter sheath 312 extends along a tortuous path to a bodily
cavity.
[0189] The elongate members 304 may be constructed from various
materials including, but not limited to, various metal and
non-metal compositions, composite materials such as carbon fiber,
or flexible PCB substrates. In some embodiments, each elongate
member 304 includes a flexible printed structure (for example, as
described with respect to FIG. 4). The elongate members 304 can
include one or more material layers. The elongate members 304 may
form an integral component of the transducer elements 306. The
elongate members 304 may also include a support for a secondary
assembly that carries the sensing and ablation transducer elements.
An example of this is a stainless steel or Nitinol structure used
to support transducer elements made with a flexible PCB circuit
structure. In some embodiments, at least some of the elongate
members 304 include resilient metallic portions. Suitable metallic
materials may include stainless steel or Nitinol by way of
non-limiting example. In some embodiments, structure 308 may
alternatively or additionally include various members, components
or assemblies other than the elongate members 304. For example, in
some embodiments, the elongate members 304 may be supported on,
located on, or provided on other structures including selectively
expandable balloons. In some embodiments, the elongate members 304
include or take the form of flexible circuit structures (e.g., 401)
which may be supported on, located on, or provided on other
structures including selectively expandable balloons.
[0190] The transducers 306 may be arranged in various distributions
or arrangements in various embodiments. In some embodiments, a set
of one or more of the transducers 306 is located on structure 308.
In some embodiments, structure 308 includes a particular portion
(e.g., first particular portion 309a) of each particular elongate
member 304 of the plurality of elongate members 304. According to
some embodiments, at least parts (e.g., first particular portions
309a) of the elongate members 304 collectively form the structure
308. In some embodiments, a respective set of one or more of the
transducers 306 is located on at least one portion (e.g., first
particular portion 309a) of a respective one of the elongate
members 304 of the plurality of elongate members. For example, in
FIG. 3B, a set of one or more of the transducers 306 is shown
located on the first particular portion 309a of each elongate
member 304, which, in some embodiments, forms part of structure
308. In some embodiments, each particular elongate member 304 of
the plurality of elongate members 304 comprises a length from a
proximal end of the particular elongate member to the distal end
305 of the particular elongate member 304, and a plurality of sets
of one or more of transducers 306 are located on distal portions
(e.g., portions 309a) of the plurality of elongate members 304,
each respective distal portion closer to, along the length of the
respective elongate member 304, the respective distal end 305 of
the respective elongate member 304 than at least some other
particular portion of the respective elongate member (e.g., the
respective non-helical twisted portion 345, the respective
particular portion 309b, and the respective second particular
portion 309c described in further detail below). In some
embodiments, each particular elongate member 304 of the plurality
of elongate members 304 comprises a length from the proximal
portion 307, 307a, or 307b of the particular elongate member 304 to
the distal end 305 of the particular elongate member 304, and a
plurality of sets of one or more of transducers 306 are located on
distal portions (e.g., portions 309a) of the plurality of elongate
members 304, each respective distal portion closer to, along the
length of the respective elongate member 304, the respective distal
end 305 of the respective elongate member 304 than at least some
other particular portion of the respective elongate member 304
(e.g., the respective non-helical twisted portion 345, the
respective particular portion 309b, and the respective second
particular portion 309c described in further detail below). In some
embodiments, each respective distal portion is distinct from or
does not include the respective distal end 305.
[0191] In some embodiments, various ones of the transducers 306 are
spaced apart from one another in a spaced apart distribution as
shown, for example, in at least FIGS. 3A and 3B at least when the
structure 308 is in an expanded or deployed configuration. In some
embodiments, various regions of space are located between various
pairs of the transducers 306. For example, in FIG. 3B the
transducer-based device system 300 includes at least a first
transducer 306a, a second transducer 306b, and a third transducer
306c (all collectively referred to as examples of transducers 306).
In some embodiments, each of the first, the second, and the third
transducers 306a, 306b, and 306c are adjacent transducers in the
spaced apart distribution. In some embodiments, the first and the
second transducers 306a, 306b are located on different elongate
members 304 (e.g., on the respective first portions 309a of the
different elongate members 304) while the second and the third
transducers 306b, 306c are located on a same elongate member 304
(e.g., on the first portion of 309a of the same elongate member
304). In some embodiments, a first region of space 350 is between
the first and the second transducers 306a, 306b. In some
embodiments, the first region of space 350 is not associated with
any physical portion of structure 308. In some embodiments, a
second region of space 360 associated with a physical portion of
transducer-based device system 300 (e.g., a portion of an elongate
member 304, such as at least part of the respective first portion
309a) is located between the second and the third transducers 306b,
306c. In some embodiments, each of the first and the second regions
of space 350, 360 does not include a transducer or electrode
thereof of electrode-based device system 300. In some embodiments,
each of the first and the second regions of space 350, 360 does not
include any transducer or electrode.
[0192] In various example embodiments, structures other than those
shown in the accompanying figures may be employed to support or
carry transducers of a transducer-based device such as a
transducer-based catheter. For example, basket catheters or balloon
catheters may be used to distribute the transducers in a
two-dimensional or three-dimensional array.
[0193] In various example embodiments, the energy transmission
surface 319 of each electrode 315 is provided by an electrically
conductive surface. In some embodiments, each of the electrodes 315
is located on various surfaces of an elongate member 304 (e.g.,
front surfaces 318a or back surfaces 318b). In this regard, in some
embodiments, each of one or more electrodes 315 is provided at
least in part on the first side or front surface 318a, the second
side or back surface 318b, or both the first side 318a and the
second side 318b of a respective elongate member 304. In some
embodiments, each of one or more electrodes 315 is located on one,
but not both of the front surface 318a and back surface 318b of a
respective elongate member 304. For example, various electrodes 315
may be located only on the respective front surfaces 318a of each
of the various ones of the elongate members 304. Three of the
electrodes 315 are identified as electrodes 315a, 315b, and 315c in
FIG. 3B. Three of the energy transmission surfaces 319 are
identified as 319a, 319b, and 319c in FIG. 3B. In various
embodiments, it is intended or designed to have the entirety of
each of various ones of the energy transmission surfaces 319 be
available or exposed (e.g., without some obstruction preventing at
least some of the ability) to contact non-fluid tissue at least
when structure 308 is positioned in a bodily cavity in the expanded
configuration. In various embodiments, it is intended or designed
to have no portion of each of at least one of the energy
transmission surfaces 319 contact fluidic tissue when the at least
one of the energy transmission surfaces 319 contacts a contiguous
portion of a non-fluidic tissue surface (e.g., a tissue surface
that defines a tissue wall).
[0194] In some embodiments, like those shown in FIG. 3B, the
respective first particular portions 309a of various ones of the
elongate members 304 are angularly arranged with respect to one
another about a first axis 335a when structure 308 is in the
expanded or deployed configuration. In some embodiments, the first
axis 335a is oblique with respect to an extension direction of a
second axis 335b (e.g., in FIG. 3B) in which the shaft member 316
extends at the distal end 316b. In this regard, the second axis
335b may be collinear with the longitudinal axis 339d of the shaft
member 316 at the distal end 316b of the shaft member 316. The
second axis 335b (or longitudinal axis 339d when collinear with the
second axis 335b) may extend through a center (e.g., centroid or
geometric center) of a cross-section of the shaft member 316 at or
adjacent the distal end 316b of the shaft member 316. It is
understood that that shaft member 316 is a flexible member in some
embodiments. Accordingly, the longitudinal axis 339d of shaft
member 316 need not be straight within various portions of shaft
member 316, but rather may follow a bend associated with these
various portions of shaft member 316. Nonetheless, the longitudinal
axis 339b extends outwardly in a straight-line path from the
proximal and distal ends 316a, 316b of shaft member 316 (for
example, as shown in FIG. 3B).
[0195] The terms "radially arranged" and "angularly arranged" may
be used interchangeably, to refer to an arrangement that is the
same or similar to lines of longitude distributed at least
partially (e.g., hemispherically) about an axis (e.g., polar or
other axis) of a body (e.g., body of revolution), which may, or may
not, be spherical.
[0196] As shown in FIG. 3C, in some embodiments, at least one of
the elongate members 304 crosses another of the elongate members
304 (for example, in an X configuration) (only two elongate members
304 called out in FIG. 3C for clarity) at a location proximate a
first axis 335a (extending into and out of the page of FIG. 3C and
illustrated with an "+" in FIG. 3C). In some embodiments, various
ones of the elongate members 304 are fanned about first axis 335a.
In some embodiments, first axis 335a passes through a plurality of
spaced apart locations along the respective length of each of at
least some of the elongate members 304 when structure 308 is in the
expanded or deployed configuration. In various embodiments, first
axis 335a may pass through two or more spaced apart locations along
the respective length of each of at least one of the elongate
members 304.
[0197] In some embodiments, each of the at least some of the
plurality of elongate members 304 includes a curved portion 337
(two called out in FIG. 3B) arranged to extend along at least a
portion of a respective curved path that intersects the first axis
335a at each of a respective at least two spaced apart locations
along first axis 335a when the structure 308 is in an expanded or
deployed configuration. In various embodiments, a curved portion
337 of an elongate member 304 may extend entirely along, or at
least part way along a respective curved path that intersects the
first axis 335a at each of a respective at least two spaced apart
locations along first axis 335a when the structure 308 is in an
expanded or deployed configuration. In some embodiments, each of
the elongate members 304 includes a curved portion 337 including a
curvature configured to cause the curved portion 337 to extend
along at least a portion of a curved path, the curvature configured
to cause the curved path to intersect the first axis 335a at each
of a respective at least two spaced apart locations along the first
axis 335a when structure 308 is in an expanded or deployed
configuration. In some embodiments, the curved path is defined to
include an imagined extension of the curved portion 337 along the
curved portion's extension direction while maintaining the curved
portion's curvature (e.g., radius of curvature or change in radius
of curvature) at a location where the curved portion 337 ends and
the imagined extension begins. In some embodiments, each curved
portion 337 may extend entirely along, or at least part way along,
the respective curved path to physically intersect at least one of
the respective at least two spaced apart locations along the first
axis 335a. In some particular embodiments, no physical portion of a
given elongate member 304 of an employed structure intersects some
of the at least two spaced apart locations along the first axis
335a intersected by the respective curved path associated with the
curved portion 337 of the given elongate member 304. In various
embodiments, the curved path is an arcuate path. In various
embodiments, at least the portion of the curved path extended along
by curved portion 337 is arcuate. In some embodiments, at least a
first elongate member 304 crosses a second elongate member 304
(e.g., in an X configuration) at each of at least one of the
respective at least two spaced apart locations along the first axis
335a intersected by at least the portion of the respective curved
path extended along by the curved portion 337 of the second
elongate member 304 when the structure 308 is in the expanded or
deployed configuration. In some embodiments, at least a first
elongate member 304 crosses a second elongate member 304 at each of
the respective at least two spaced apart locations along the first
axis 335a intersected by at least the portion of the respective
curved path extended along by the curved portion 337 of the second
elongate member 304 when the structure 308 is in an expanded or
deployed configuration. In various embodiments, each respective
curved portion 337 is arranged to extend along at least a portion
of a respective curved path that intersects the first axis 335a at
each of a respective at least two spaced apart locations along
first axis 335a when the structure 308 is in an expanded or
deployed configuration.
[0198] In various embodiments, various particular portions of all
of the plurality of elongate members 304 are circumferentially
arranged about first axis 335a when the structure 308 is in an
expanded or deployed configuration. For example, when the structure
308 is the expanded or deployed configuration, at least respective
parts of the elongate members 304 (e.g., at least the first
particular portion 309a or the curved portion 337) are
circumferentially arranged about the first axis 335a, in the same
or similar manner as lines of longitude about an axis of a body,
which body may, or may not, be spherical. In some embodiments, at
least one portion (e.g., the first particular portion 309a or the
curved portion 337) of each of the elongate members 304 extends
like a line of longitude about the structure 308 when the structure
is in the deployed or expanded configuration. In some embodiments,
at least one portion (e.g., at least the first particular portion
309a or the curved portion 337) of each elongate member 304 is not
arranged in a helical configuration when the structure 308 is in an
expanded or deployed configuration. It is noted in various
embodiments that various particular portions of the elongate
members may include configurations in each of the delivery and the
deployed configurations that differ from one another on aspects
other than differences in size. Other aspects can include inherent
differences in structure. For example, according to some
embodiments, the first particular portions 309a of the elongate
members 304 are arranged like lines of longitude in the expanded or
deployed configuration shown in FIG. 3B and are arranged in a
stacked configuration in an unexpanded or delivery configuration
shown in FIG. 3A. Without limitation, other arrangements of some of
the various particular portions of the elongate members 304 are
possible in various embodiments. In some embodiments, at least one
portion (e.g., first particular portion 309a) of each elongate
member 304 is not arranged in a helical configuration when the
structure 308 is in an unexpanded or delivery configuration. In
some embodiments, at least one portion (e.g., first particular
portion 309a) of each elongate member 304 is not arranged in a
helical configuration when the structure 308 is in an expanded or
deployed configuration.
[0199] In some embodiments, each of the elongate members 304
includes a respective portion (e.g., at least part of first
particular portion 309a or at least part of curved portion 337)
radially spaced from the first axis 335a when the structure 308 is
in an expanded or deployed configuration, the respective portions
of the elongate members 304 circumferentially arranged about the
first axis 335a when the structure is in the expanded
configuration. Similarly, in various embodiments, at least some of
the electrodes 315 are radially spaced about or from a first axis
335a when structure 308 is in an expanded or deployed
configuration. In various embodiments, at least some of the
electrodes 315 are circumferentially arranged about first axis 335a
when structure 308 is in the deployed configuration. For example,
various ones of the electrodes 315 are circumferentially arranged
about first axis 335a in the expanded or deployed configuration in
at least some of the embodiments associated with various ones of at
least FIG. 3B. It is understood that although electrodes 315 are
referred to in these described embodiments, the same analysis
applies to the corresponding transducers 306 in some embodiments.
In various embodiments, the electrodes 315 are arranged such that
the first axis 335a passes through, or alternatively does not pass
through a particular electrode (e.g., a central electrode). The
presence or non-presence of such a particular electrode may be
dependent on various factors including a required size of the
device and particular anatomy characteristics into which the device
is deployed. For example, different bodily cavities have different
sizes and shapes and, therefore, different sizes and shapes of
various parts of the transducer-based device system 300 (e.g.,
structure 308) may be appropriate to match the different sizes and
shapes of the bodily cavities, according to some embodiments.
Different bodily cavities may have different anatomical features or
different positionings of various anatomical features. Accordingly,
in some embodiments, it may be beneficial to have an arrangement of
transducers or electrodes in which an electrode intersected by
first axis 335a exists. In other applications, it may be beneficial
to have an arrangement of transducers or electrodes in which an
electrode intersected by first axis 335a does not exist.
[0200] It may be noted that distances between adjacent ones of the
elongate members 304 shown in at least FIG. 3B vary as elongate
members 304 extend toward first axis 335a when structure 308 is in
the deployed configuration. In some cases, the varying distances
between adjacent elongate members 304 in an expanded or deployed
configuration may give rise to shape, size or dimensional
constraints for the electrodes 315 located on the elongate members
304. In some cases, the overlapping portions of various ones of the
elongate members 304 in the deployed configuration may give rise to
shape, size or dimensional constraints for the electrodes 315
located on the portions of the various ones of the elongate members
304. For example, it may be desirable to reduce a surface area of
an electrode adjacent an overlap region on an overlapped elongate
member to accommodate the reduced exposed surface area of the
overlapped elongate member in the region adjacent the overlap
region.
[0201] In various embodiments, the respective shape of various
electrically conductive surfaces (e.g., energy transmission
surfaces 319) of various ones of the electrodes 315 vary among the
electrodes 315. In various embodiments, the respective shape of
various electrically conductive surfaces (e.g., energy transmission
surfaces 319) of various ones of the electrodes 315 vary among the
electrodes 315 in accordance with their proximity to first axis
335a. In various embodiments, one or more dimensions or sizes of
various electrically conductive surfaces (e.g., energy transmission
surfaces 319) of at least some of the electrodes 315 vary among the
electrodes 315. In various embodiments, one or more dimensional
sizes of various electrically conductive surfaces (e.g., energy
transmission surfaces 319) of at least some of the electrodes 315
vary in accordance with their proximity to first axis 335a. The
shape or size variances associated with various ones of the
electrodes 315 may be motivated for various reasons. For example,
in various embodiments, the shapes or sizes of various ones of the
electrodes 315 may be controlled in response to various ones of the
aforementioned size or dimensional constraints.
[0202] Referring back to FIGS. 2A and 2B, it is noted that
structure 308 may be required to be positioned in, or to be
positionable in, a bodily cavity (e.g., left atrium 204) in
different positions or orientations. The required variances in
position, orientation, or both position and orientation may be
motivated for different reasons. For example, different regions of
the bodily cavity may need to be diagnosed or treated based on
typical and non-typical anatomical variations as well as variances
in the anatomical regions that are susceptible to a particular
disease or diseases, or are afflicted by a particular disease or
diseases. In various embodiments, the ability to position the
structure 308 at multiple different locations or in multiple
different orientations may be dependent on the ability of shaft
member 316 to bend, or be bent, in multiple different directions.
For example, a comparison of FIGS. 2A and 2B shows different
degrees of bending in shaft member 316 required to position
structure 308 into two different sets of positions and
orientations. In some embodiments, different degrees of bending in
shaft member 316 are required during percutaneous or intravascular
delivery of at least part of catheter 314 especially through bodily
opening providing a tortuous path. In some embodiments, it is
desired that shaft member 316 include at least one bendable portion
that is bendable in each of at least two intersecting planes (e.g.,
two orthogonal planes) to position structure 308 in different
positions and orientations. The at least one bendable portion of
the shaft member 316 may, in some embodiments, be actively bendable
in each of the at least two intersecting planes. For example, in
some embodiments, catheter 314 may itself include various controls
coupled to the at least one bendable portion via various control
elements to bend the at least one portion in response to activation
of at least some of the control elements. By way of non-limiting
example, catheter 314 may include various actuators, each coupled
to a respective set of control lines to bend the at least one
bendable portion in at least one of the at least two intersecting
planes. By way of non-limiting example, catheter 314 may include
various actuators, each coupled to a respective set of control
lines located internally within the catheter 314 (e.g., within a
lumen in shaft member 316) to bend the at least one bendable
portion in at least one of the at least two intersecting planes. In
some embodiments, at least one bendable portion of the shaft member
316 may, in some embodiments, be passively bendable in each of the
at least two intersecting planes. For example, the at least one
bendable portion is sufficiently compliant to bend in response to
externally applied force or forces to catheter 314 (e.g., external
forces applied to an outer or external surface of shaft member
316).
[0203] In various embodiments, the ability to position the
structure 308 at multiple different locations or in multiple
different orientations may be dependent on the ability of various
particular portions of each of at least some of the elongate
members 304 to bend, or be bent, in multiple different directions.
In various embodiments, the ability to position the structure 308
at multiple different locations or in multiple different
orientations may be dependent on the ability of various particular
portions of each of at least some of the elongate members 304 to
bend, or be bent, in each of the at least two intersecting planes
(e.g., two orthogonal planes).
[0204] In some cases, various arrangements of particular portions
of the elongate members 304 may hinder or otherwise restrict the
ability of various parts of the elongate members 304 from bending
in multiples directions (e.g., bending in each of the at least two
intersecting planes). For example, in a manner similar to the
stacked arrangement of the first particular portions 309a, the
second particular portions 309c may also be stacked front surface
318a-toward-back surface 318b along a particular direction 338b
(FIG. 3A) in a stacked arrangement according to some embodiments.
In various embodiments, the second particular portions 309c may be
located within catheter shaft 316 itself. In a manner similar to
the spatially efficient stacked arrangement adopted, according to
some embodiments, by the first particular portions 309a to reduce
the overall cross-sectional size of the catheter sheath 312 which
the first particular portions 309a are delivered therethrough,
stacking of the second particular portions 309c may be employed to
create a spatially efficient arrangement that can be advantageously
employed to reduce a cross-sectional size of the catheter shaft 316
in which the second particular portions 309c are located in or
housed in according to some embodiments. It is noted, however,
that, in some cases, a particular arrangement of particular
portions of the elongate members 304 (e.g., a stacked arrangement
of second particular portions 309c) may have different bending
characteristics or degrees of flexibility when required to bend in
different directions (e.g., when required to bend in each of the at
least two intersecting planes). For example, the stacked
arrangement of second particular portions 309c may bend more easily
in their stacking direction 338b than in a direction orthogonal to
their stacking direction 338b (e.g., in a direction across the
widths 323 of the second particular portions 309c). In some cases,
each width 323 is larger than the thickness 327 of the particular
portion of the elongate member 304 and, thus, bending across the
width is restricted or impeded by a greater amount than bending
across the thickness (i.e., the elongate members being stiffer
across their widths 323 than across their thickness 327). It is
noted that different resistances to bending in different directions
is not confined to stacked arrangements as other arrangements may
also be affected by this condition. For example, an arrangement of
various members whose cross-section comprises different dimensions
in each of at least two different bending directions may typically
experience different bending resistances in each of the at least
two different bending directions. By way of another example, an
arrangement of various members whose cross-section comprises
different distributions of the members in each of at least two
different bending directions may typically experience different
bending resistances in each of the at least two different bending
directions.
[0205] In some cases, differential bending characteristics in each
of multiple bending directions may hinder positioning of structure
308. In some cases, bending resistance in each of at least one of
multiple bending directions may hinder positioning of structure
308. In some cases, a particular arrangement of particular portions
of the elongate members 304 is located within shaft member 316. If
the particular arrangement of particular portions of the elongate
members 304 provides sufficient bending resistance in each of at
least one of multiple bending directions, bending of various
portions of the shaft member 316 may be impeded or restricted along
each of at least one particular direction. It is noted that bending
resistance along a particular direction is not solely attributable
to stacked arrangements and may also be associated with other types
of arrangements of various particular portions of the elongate
members 304. For example, a bundled arrangement of particular
portions of the elongate members 304 may provide bending resistance
along each of at least one particular direction.
[0206] Various embodiments of the present invention may be employed
to, among other things, address these bending restrictions at least
with a helical configuration in some embodiments, or a twisted,
non-helical configuration in some embodiments, of the elongate
members 304, which facilitate improved bending characteristics
thereof. Consequently, improved percutaneous or intravascular
navigation of the shaft member 316 and positioning of the structure
308 within a bodily cavity may be achieved.
[0207] For example, FIGS. 3G and 3H show detailed portions of shaft
member 316 and portions of elongate members 304 in a double-helical
configuration when structure 308 is in an unexpanded or delivery
configuration (e.g., as shown in FIG. 3A), according to some
embodiments. For clarity, various portions of the shaft member 316
are not shown in FIGS. 3G and 3H to allow various particular
portions (e.g., second particular portions 309c) of the elongate
members 304 to be seen. For further clarity, catheter sheath 312 is
also not shown in FIGS. 3G and 3H. As can be seen by a comparison
of FIGS. 3G and 3H, the double-helical configuration of portions of
elongate members 304 within shaft member 316 allow for improved
bending characteristics of at least such portions of the elongate
members 304, as well as of at least the corresponding portion of
shaft member 316.
[0208] Turning to FIG. 3G, according to some embodiments, each of
the elongate members 304 includes a second portion or second
particular portion 309c. Each second particular portion 309c of
each elongate member 304 may be arranged in a helical configuration
when the structure 308 is in an unexpanded or delivery
configuration. According to various embodiments, such a helical
configuration allows for uniform or substantially uniform bending
characteristics of the shaft member 316 in at least two different
bending directions. For example, the helical configuration
distributes the second particular portions 309c circumferentially
around an axis (e.g., a longitudinal axis of the shaft member 316
or other axis of rotation) in a series of spaced apart coils, each
coil axially spaced from an adjacent coil. The presence of these
axial spaces allows the second particular portions 309c to bend
with substantially the same amount of bending resistance in each of
the at least two different bending directions. Accordingly, in
various embodiments, such a helical configuration may facilitate
reduced differences in bending resistance in each of at least two
different bending directions. In this regard, it is noted that the
helical configuration of the elongate members 304, e.g., within
portions 309c, provides improved bending characteristics, in
contrast to the non-helical twisted portion 345, which facilitates
changing of the structure 308 between its delivery or unexpanded
configuration and its deployed or expanded configuration.
Additionally, in some embodiments, each of the helical second
particular portions 309c is spaced from a central rotational axis
along which they are wound while the non-helical twisted portions
345 are not spaced from their central rotational axis. In some
embodiments, the helical configuration includes at least 360
degrees of rotation when the structure 308 is in the unexpanded or
delivery configuration. In some embodiments, the helical
configuration includes at least 540 degrees of rotation when the
structure 308 is in the unexpanded or delivery configuration. In
some embodiments, the helical configuration includes at least 720
degrees of rotation when the structure 308 is in the unexpanded or
delivery configuration. Higher degrees of rotation may facilitate
improved bending characteristics in different directions, e.g.,
over a longer region or length of the elongate members 304.
[0209] Although FIGS. 3G and 3H illustrate a multi-helical
configuration according to some embodiments, other helical
configurations or non-helical twisted configurations including at
least 360 degrees of rotation also improve bending characteristics
as compared to non-helical non-twisted or substantially non-twisted
configurations. For example, FIG. 3D illustrates a set 304y of at
least some of the elongate members 304 arranged in a single helical
configuration rotating around a plurality of control elements 356
(only one instance of a control element 356 is called out in FIG.
3D for clarity), according to some embodiments. For another
example, FIG. 3E illustrates a first set 304y of at least some of
the elongate members 304 and a second set 304z of at least some of
the elongate members 304 arranged in a double helical configuration
rotating around a plurality of control elements 356 (only one
instance of a control element 356 is called out in FIG. 3E for
clarity), according to some embodiments. For yet another example,
FIG. 3F illustrates a set 304y of at least some of the elongate
members 304 arranged in a twisted, non-helical configuration
rotating alongside a plurality of control elements 356 (only one
instance of a control element 356 is called out in FIG. 3F for
clarity), according to some embodiments.
[0210] As can be seen by a comparison of the example helical
configurations of FIGS. 3D and 3E with the example twisted,
non-helical configuration of FIG. 3F, the helical configurations
provide an interior channel, where the axis of rotation resides,
for the one or more control elements 356 to reside. Accordingly, a
set of one or more elongate members 304 in a helical configuration
may rotate around the one or more control elements 356. On the
other hand, because the twisted, non-helical configuration
intersects its axis of rotation, the one or more control elements
356 are located alongside the set 304y of at least some of the
elongate members 304 in FIG. 3F, instead of the set 304y of at
least some of the elongate members 304 rotating around the one or
more control elements 356. While, in some implementations, a
helical configuration with at least some of the elongate members
304 rotating or wrapping around one or more control elements 356
(e.g., FIGS. 3D, 3E, or 3G and 3H) may provide improved bending
characteristics and space utilization efficiency characteristics as
compared to a non-helical twisted configuration with at least some
of the members 304 rotating side-by-side with one or more control
elements 356 (e.g., FIG. 3F), it may be less expensive, in some
implementations, to produce a non-helical twisted configuration
(e.g., FIG. 3F) as compared to a helical configuration (e.g., FIGS.
3D, 3E, or 3G and 3H), while still maintaining improved bending
characteristics as compared to a non-helical, non-twisted
configuration. Accordingly, depending on need, a helical
configuration or a non-helical, twisted configuration may be
preferable.
[0211] Although FIGS. 3D, 3E, and 3F each illustrate five control
elements 356, different numbers of control elements may be
implemented in different embodiments. Also, it is noted that the
control elements 356 illustrated in FIGS. 3D, 3E, and 3F are
themselves arranged in a helical configuration, which may further
improve bending characteristics. Further, each of FIGS. 3D, 3E, and
3F illustrate a single, twisting, thick `block` as a set of
elongate members (e.g., 304y, 304z), it is understood that such
single, rotating, `thick block` is intended to illustrate in a
simple manner for clarity at least some of the elongate members
304, depending on the embodiment, and the illustrated thickness of
such single, `thick block` is not intended to limit or define the
actual thickness of any particular elongate member 304 or stack of
elongate members 304. Further, different embodiments utilize
different numbers of elongate members. Accordingly, for example,
the first set 304y of at least some of the elongate members 304
illustrated in FIG. 3D may or may not have the same number of
elongate members 304 as the first set 304y of at least some of the
elongate members 304 illustrated in FIG. 3E or FIG. 3F. The same
applies to other illustrations in the figures, such as at least the
second set 304z of at least some of the elongate members 304
illustrated in FIG. 3E with respect to the first set 304y of at
least some of the elongate members 304 illustrated in each of FIGS.
3D, 3E, and 3F. Also, although FIGS. 3D, 3E, and 3F illustrate
particular locations of control elements 356, other embodiments
have one or more control elements 356 in other locations.
[0212] In various embodiments, each of the plurality of the
elongate members 304 includes a first portion (e.g., first portion
or first particular portion 309a) that extends outwardly from the
shaft distal end 316b of the shaft member 316 and further includes
a second portion (e.g., second portion or second particular portion
309c) that is located within the elongated portion 316c of the
shaft member 316. According to various embodiments, at least one
portion (e.g., first particular portion 309a) of each elongate
member 304 has located thereon a respective set of one or more of
the transducers 306. In some embodiments, at least one portion
(e.g., first particular portion 309a) of each elongate member 304
other than the second portion (e.g., second particular portion
309c) of the elongate member 304 has located thereon a respective
set of one or more of the transducers 306. According to some
embodiments, no transducer or electrode (e.g., a transducer
selectively operable to transmit energy) is located on the second
portions (e.g., second particular portions 309c) of the elongate
members 304. In some embodiments, each second portion (e.g., second
particular portion 309c) of each of at least one of the elongate
members 304 does not include any transducers or electrodes. In some
embodiments, each second portion (e.g., second particular portion
309c) located within the elongated portion 316c of the shaft member
316 includes a helical configuration (e.g., FIGS. 3D, 3E, or 3G and
3H) or includes a non-helical twisted configuration (e.g., FIG.
3F). In some embodiments, each second portion located within the
elongated portion 316c of the shaft member 316 includes a helical
configuration that includes at least 360 degrees of rotation, at
least 540 degrees of rotation in some embodiments, or at least 720
degrees of rotation in some embodiments to facilitate enhanced
bending characteristics in 360 degrees. In some embodiments, each
second portion located within the elongated portion 316c of the
shaft member 316 includes a twisted, non-helical configuration that
includes at least 360 degrees of rotation, at least 540 degrees of
rotation in some embodiments, or at least 720 degrees of rotation
in some embodiments to facilitate enhanced bending characteristics
in 360 degrees.
[0213] In various embodiments, the second particular portions 309c
of the elongate members 304 each maintain a helical configuration
or a twisted, non-helical configuration during a movement of the
structure 308 between the unexpanded or delivery configuration and
the expanded or deployed configuration. In various embodiments, the
second particular portions 309c of the elongate members 304 each
maintain a helical configuration or a twisted, non-helical
configuration in each of the unexpanded or delivery configuration
and the expanded or deployed configuration. In various embodiments,
the second particular portions 309c of the elongate members 304 are
arranged in a particular configuration that (a) remains
sufficiently small in size, or (b) undergoes no particular change
in size sufficient to restrict the second portions 309c from being
too large, to be percutaneously or intravascularly deliverable to a
bodily cavity when the structure 308 is moved from the unexpanded
or delivery configuration to the expanded or deployed
configuration. For example, in some embodiments, the act of moving
structure 308 from the unexpanded or delivery configuration to the
expanded or deployed configuration involves no particular actuation
or transmission of force that would increase a size (e.g., a
cross-sectional diameter) of a particular configuration (e.g., the
helical configuration) of the second particular portions 309c that
would restrict the second particular portions 309c from being
percutaneously or intravascularly deliverable to a bodily cavity.
Even though the second particular portions 309c are located,
confined, or encapsulated within a particular structure (e.g., a
lumen of elongated potion 316c of shaft member 316) in some
embodiments, the second particular portions 309c of the elongate
members 304 are arranged in a particular configuration, according
to some embodiments, that would remain sufficiently small in size
to be percutaneously or intravascularly deliverable to a bodily
cavity in absence of the particular structure, when the structure
308 is moved from the unexpanded or delivery configuration to the
expanded or deployed configuration.
[0214] Returning to a comparison of FIGS. 3G and 3H, such figures
show that the helical configuration of the second particular
portions 309c, according to some embodiments, facilitates bending
of at least the second particular portions 309c especially in each
of multiple different directions (e.g., (a) different directions
lying on one plane or (b) different directions lying in each of at
least two intersecting planes, or both (a) and (b)). This
facilitated bending can enhance the ability to maneuver structure
308 into different positions or different orientations. In some
embodiments in which the second particular portions 309c are
located within the elongated portion 316c of shaft member 316, each
of various ones of the second particular portions 309c may employ a
helical configuration to enhance an ability of shaft member 316 to
bend in each of different directions. As discussed above, a
twisted, non-helical configuration of a portion or portions of one
or more elongate members within the shaft member 316 provides
similar bending enhancements.
[0215] In various embodiments, where certain particular portions of
the elongate members are arranged in a first particular
configuration to provide a particular desired function (e.g.,
spatial efficiency) with the particular configuration not conducive
or best suited for a second particular desired function (e.g.,
improved bendability), the incorporation of the helical or twisted,
non-helical second particular portions may allow the second
particular desired function to be achieved at least in part. For
example, if the particular portions 309b of the elongate members
304 continued in their non-twisted, non-helical stacked
configuration through a particular part of the elongate portion
316c of the shaft member 316, their non-twisted, non-helical
stacked configuration may restrict or hinder the bendability of the
particular part of the elongated portion 316c of the shaft member
316 in at least one direction. The use the helical or twisted,
non-helical second particular portions 309c may be employed to
improve the bendability of the particular part of the elongate
portion 316c of the shaft member 316 in at least the one direction
or in another direction.
[0216] In some embodiments, the second particular portions 309c of
the elongate members 304 are arranged in a collective arrangement
that may be motivated for various particular reasons. For example,
in various embodiments, it may be desired that the second
particular portions 309c be arranged in a particular arrangement
that can accommodate various constraints (e.g., spatial
constraints). In some embodiments in which the second particular
portions 309c are contained within the elongated portion 316c of
shaft member 316, the second particular portions 309c are
preferably arranged in an arrangement that can accommodate the
spatial confines of the elongated portion 316c. In some
embodiments, the second particular portions 309c are arranged in a
non-orderly, random, or quasi-random arrangement with no
substantial form or structure to the arrangement. In some
embodiments, the second particular portions 309c are arranged in an
orderly arrangement.
[0217] In many cases, an orderly arrangement is typically more
spatially efficient than a non-orderly arrangement. A stacked
arrangement is an example of an orderly arrangement that is
spatially efficient. A nested configuration is also an example of
an orderly configuration that is spatially efficient. For example,
a particular portion of a first elongate member 304 may be nested
with a particular portion of at least a second elongate member 304
at least when the structure is in (a) an unexpanded or delivery
configuration, (b) an expanded or deployed configuration or in each
of (a) and (b). In some embodiments, the second particular portion
309c of a first elongate member 304 may be nested with the second
particular portion 309c of at least a second elongate member 304 at
least when the structure is in (a) an unexpanded or delivery
configuration, (b) an expanded or deployed configuration, or in
each of (a) and (b). In some embodiments, particular portions of
the elongate members 304 are arranged such that at least a
particular portion of the front surface 318a of a first elongate
member 304 follows a contour of at least a particular portion 318b
of a second elongate member 304 at least when the structure is in
(a) an unexpanded or delivery configuration, (b) an expanded or
deployed configuration, or in each of (a) and (b). In some
embodiments the particular portion of the front surface 318a of the
first elongate member 304 faces (and, in some embodiments contacts)
the particular portion 318b of a second elongate member 304 at
least when the structure is in (a) an unexpanded or delivery
configuration, (b) an expanded or deployed configuration or in each
of (a) and (b) and as such may be considered to be facing or
contacting portions. In some embodiments, particular portions of
the elongate members 304 are arranged such that at least a
particular portion of the front surface 318a of a first elongate
member 304 follows a contour of at least the particular portion
318b of a second elongate member 304 throughout the helical
rotation of the second portion 309c of the second elongate member
304 at least when the structure is in (a) an unexpanded or delivery
configuration, (b) an expanded or deployed configuration or in each
of (a) and (b).
[0218] FIGS. 3G and 3H illustrate a first set 309c-1 of the second
particular portions 309c of a first set 309c-1a of the elongate
members 304, and a second set 309c-2 of the second particular
portions 309c of a second set 309c-2a of the elongate members 304.
The first set 309c-1 of the second particular portions 309c may
correspond to the portion of the first set 304y of at least some of
the elongate members 304 illustrated in FIG. 3E, according to some
embodiments, and the second set 309c-2 of the second particular
portions 309c may correspond to the portion of the second set 304z
of at least some of the elongate members 304 illustrated in FIG.
3E, according to some embodiments. As shown in FIGS. 3G and 3H, the
first set 309c-1 of the second particular portions 309c of the
first set 309c-1a of the elongate members 304 may be axially or
longitudinally (along the longitudinal axis of the shaft member
316) offset from the second set 309c-2 of the second particular
portions 309c of the second set 309c-2a of the elongate members 304
according to some embodiments. In some embodiments, the first set
309c-1a of the elongate members 304 includes at least two or at
least three elongate members 304. In some embodiments, the second
set 309c-2a of the elongate members 304 includes at least two or at
least three elongate members 304. In some embodiments, the first
set 309c-1a of the elongate members 304 has exactly four elongate
members 304, and the second set 309c-2a of the elongate members 304
has exactly four elongate members 304. In this regard, as with the
above-discussion regarding FIGS. 3D, 3E, and 3F regarding the
possibilities of different numbers of elongate members 304 in
different embodiments, the first set 309c-1a of the elongate
members 304 may have the same number of elongate members 304 as the
second set 309c-2a of the elongate members 304 in some embodiments,
but in other embodiments, the first set 309c-1a of the elongate
members 304 has a different number of elongate members 304 than the
second set 309c-2a of the elongate members 304. The different
number may be plus-or-minus one (1), e.g., in the case of an odd
number of elongate members 304, such as seven elongate members 304,
which may be provided in some embodiments. In some embodiments, the
different number is plus-or-minus 20% or 10% to allow for
differences, but still ensuring an integer number of elongate
members 304 in each set 309c-1a, 309c-2a. In some embodiments, the
different number is plus-or-minus 20% or 10% to allow for
differences, but still facilitating substantially balanced bending
characteristics. In various embodiments, the elongate members 304
of the first set 309c-1a are other than the elongate members of the
second set 309c-2.
[0219] In some embodiments, e.g., as shown in FIGS. 3G and 3H, the
first set 309c-1 of the second particular portions 309c of the
first set 309c-1a of the elongate members 304 forms a first
collective helical configuration, and the second set 309c-2 of the
second particular portions 309c of the second set 309c-2a of the
elongate members 304 forms a second collective helical
configuration. In this regard, FIGS. 3G and 3H show an example
where a particular portion (e.g., second particular portion 309c)
of a first elongate member 304-1a1 in the first set 309c-1a is
nested with a particular portion (e.g., second particular portion
309c) of at least an adjacent second elongate member 304-1a2 in the
first set 309c-1a at least when the structure 308 is in an
unexpanded or delivery configuration, according to some
embodiments. Since, in some embodiments, the second particular
portions 309c maintain their helical configurations when the
structure 308 moves from its delivery or unexpanded configuration
to its deployed or expanded configuration, the particular portion
(e.g., second particular portion 309c) of the first elongate member
304-1a1 in the first set 309c-1a also may be nested with the
particular portion (e.g., second particular portion 309c) of at
least the adjacent second elongate member 304-1a2 in the first set
309c-1a when the structure 308 is in an expanded or deployed
configuration, according to some embodiments. The same unexpanded
or delivery configuration and expanded or deployed configuration
nesting characteristics apply to adjacent first and second elongate
members 304-2a1, 304-2a2, respectively, in the second set 309c-2a
of the elongate members 304, according to some embodiments.
[0220] In some embodiments, particular portions of the elongate
members 304 are arranged such that at least a particular portion of
the front surface 318a of a first elongate member 304 (e.g., first
elongate member 304-1a1 of first set 309c-1a) follows a contour of
at least a particular portion of the back surface 318b of a second
elongate member 304 (e.g., second elongate member 304-1a2 of first
set 309c-1a) at least (a) when the structure 308 is in an
unexpanded or delivery configuration (e.g., as shown in FIGS. 3G
and 3H), (b) when the structure 308 is in an expanded or deployed
configuration (e.g., due to the retention of the helical
configuration of the second particular portions 309c when the
structure moves to the expanded or delivery configuration in some
embodiments), or both (a) and (b). In some embodiments, the
particular portion of the front surface 318a of the first elongate
member 304 faces the particular portion of the back surface 318b of
the second elongate member 304 at least (a) when the structure 308
is in an unexpanded or delivery configuration, (b) when the
structure 308 is in an expanded or deployed configuration, or both
(a) and (b). In some embodiments, the particular portion of the
front surface 318a of the first elongate member 304 faces (and, in
some embodiments contacts) the particular portion of the back
surface 318b of the second elongate member 304 at least (a) when
the structure 308 is in an unexpanded or delivery configuration,
(b) when the structure 308 is in an expanded or deployed
configuration, or both (a) and (b) and, as such, the particular
portion of the front surface 318a of the first elongate member 304
and the particular portion of the back surface 318b of the second
elongate member 304 may be considered facing or contacting
portions. In some embodiments, the particular portion of the front
surface 318a of the first elongate member 304 and the particular
portion of the back surface 318b of the second elongate member 304
are provided by the respective second particular portions 309c of
the respective elongate members 304. In some embodiments, the
particular portion of the front surface 318a of the first elongate
member 304 (e.g., first elongate member 304-1a1 of first set
309c-1a) follows the contour of (and, in some embodiments,
contacts) at least the particular portion of the back surface 318b
of the second elongate member 304 (e.g., second elongate member
304-1a2 of first set 309c-1a) throughout the helical rotation of
the second portion 309c of the second elongate member 304 at least
(a) when the structure 308 is in an unexpanded or delivery
configuration, (b) when the structure 308 is in an expanded or
deployed configuration, or both (a) and (b). In some embodiments,
the helical rotation is at least 360 degrees of rotation, in some
embodiments, the helical rotation is at least 540 degrees of
rotation, and in some embodiments, the helical rotation is at least
720 degrees of rotation. Various embodiments in which the elongate
members 304 or portions thereof arranged with contours that follow
each other may provide spatially efficient arrangements.
[0221] Further describing spatially efficient arrangements, in some
embodiments, at least the second particular portions 309c of a
first set (e.g., first set 309c-1a) of the plurality of elongate
members 304 are arranged front surface 318a-toward-back surface
318b in a stacked arrangement (e.g., a helical stacked arrangement
such as that shown in Figured 3G and 3H) at least when the
structure 308 is in an unexpanded or a delivery configuration. For
example, in each of FIGS. 3G and 3H, the first set 309c-1 of the
second particular portions 309c of the first set 309c-1a of
elongate members 304 are arranged front surface 318a-toward-back
surface 318b in a first stacked arrangement at least when the
structure 308 is in an unexpanded or a delivery configuration,
according to some embodiments. Since, for example, in some
embodiments, the second particular portions 309c maintain their
helical configurations within shaft member 316 when the structure
308 moves from its delivery or unexpanded configuration to its
deployed or expanded configuration, the first set 309c-1 of the
second particular portions 309c of the first set 309c-1a of
elongate members 304 are arranged front surface 318a-toward-back
surface 318b in a second stacked arrangement at least when the
structure 308 is in an expanded or a deployed configuration,
according to some embodiments. In some embodiments, the first and
second stacked arrangements in this regard are helical stacked
arrangements.
[0222] The same just stated for the first set 309c-1 of the second
particular portions 309c of the first set 309c-1a of elongate
members 304 also applies to the second set 309c-2 of the second
particular portions 309c of the second set 309c-2a of elongate
members 304 in some embodiments. For example, in each of FIGS. 3G
and 3H, the second set 309c-2 of the second particular portions
309c of the second set 309c-2a of elongate members 304 are arranged
front surface 318a-toward-back surface 318b in a first stacked
arrangement at least when the structure 308 is in an unexpanded or
a delivery configuration, according to some embodiments. Since, for
example, in some embodiments, the second particular portions 309c
maintain their helical configurations within shaft member 316 when
the structure 308 moves from its delivery or unexpanded
configuration to its deployed or expanded configuration, the second
set 309c-2 of the second particular portions 309c of the second set
309c-2a of elongate members 304 are arranged front surface
318a-toward-back surface 318b in a second stacked arrangement at
least when the structure 308 is in an expanded or a deployed
configuration, according to some embodiments. As mentioned above,
in some embodiments, the first and second stacked arrangements in
this regard are helical stacked arrangements. Also as mentioned
above, each of the first set 309c-1a and the second set 309c-2a of
elongate members 304 may include at least two or at least three
elongate members 304 according to some embodiments.
[0223] In some embodiments, the first set 309c-1 of the second
particular portions 309c of the first set 309c-1a of elongate
members 304 are arranged front surface 318a-toward-back surface
318b in a first stacked arrangement at least (a) when the structure
308 is in an unexpanded or a delivery configuration, (b) when the
structure 308 is in an expanded or deployed configuration, or both
(a) and (b), according to some embodiments. In some embodiments,
the second particular portions 309c of the second set 309c-2a of
elongate members 304 are arranged front surface 318a-toward-back
surface 318b in a second stacked arrangement at least (a) when the
structure 308 is in an unexpanded or a delivery configuration, (b)
when the structure 308 is in an expanded or deployed configuration,
or both (a) and (b), according to some embodiments. In this regard,
the first stacked arrangement may be axially or longitudinally
(along the longitudinal axis of the shaft member 316) offset from
the second stacked arrangement, as shown, for example in each of
Figured 3G and 3H, with the axial or longitudinal offset of the
first set 309c-1 of the second particular portions 309c with
respect to the second set 309c-2 of the second particular portions
309c. As mentioned above, in some embodiments, the first and second
stacked arrangements in this regard are helical stacked
arrangements. Also as mentioned above, each of the first set
309c-1a and the second set 309c-2a of elongate members 304 may
include at least two or at least three elongate members 304
according to some embodiments.
[0224] In some embodiments, e.g., as shown in FIGS. 3G and 3H,
while each second particular portion 309c may itself form its own
helical configuration, the first set 309c-1 of the second
particular portions 309c of the first set 309c-1a of the elongate
members 304 may form a first collective helical configuration, and
the second set 309c-2 of the second particular portions 309c of the
second set 309c-2a of the elongate members 304 may form a second
collective helical configuration at least (a) when the structure
308 is in an unexpanded or delivery configuration, (b) when the
structure 308 is in an expanded or deployed configuration, or both
(a) and (b). In some embodiments, (i) the first collective helical
configuration is a first collective helical configuration, e.g.,
forming a single collective helix, (ii) the second collective
helical configuration is a second single collective helical
configuration, e.g., forming a single collective helix, or both (i)
and (ii). In this regard, the individual helical configurations of
the respective individual second particular portions 309c may be
combined (e.g., by nesting or contour following described above) to
form one or more collective helical configurations. In some
embodiments, the first collective helical configuration and the
second collective helical configuration together form multiple
collective (double in the case of FIGS. 3G and 3H) helical
configurations similar to a multi-helix structure such as the
double helix structure employed by DNA (Deoxyribonucleic acid).
Another example of such a collective multiple helical configuration
may be envisioned as including a form similar to a screw type
mechanical device (e.g., a screw-type fastener or lead-screw)
comprising a multi-start threaded form that includes more than one
(commonly two to four) parallel, non-crossing helix according to
some embodiments. These examples are non-limiting and the sets may
be grouped to form other collective helical configurations. In some
embodiments, each collective helical configuration is arranged such
that the respective set of second particular portions 309c are
combined in one or more arrangements that each have a helical
arrangement or configuration. In some embodiments, each collective
helical configuration is arranged such that a grouping of the
respective set of second particular portions 309c in each of one or
more arrangements has a helical configuration. Just as some
embodiments have multiple helical configurations (e.g., FIGS. 3E,
3G, and 3H) as compared to embodiments that have a single helical
configuration (e.g., FIG. 3D), some embodiments may have multiple
twisted, non-helical configurations as compared to embodiments that
have a single twisted, non-helical configuration (e.g., FIG.
3F).
[0225] According to some embodiments, such as those shown in FIGS.
3G and 3H, the second particular portions 309c in the first set
309c-1a of the elongate members 304 are axially or longitudinally
offset (e.g., offset along a longitudinal axis of shaft member 316
or along an axis of a helix associated with the second particular
portions 309c in either of the first set 309c-1a or the second set
309c-2a) from the second particular portions 309c in the second set
309c-2a of the elongate members 304 at least when the structure 308
(a) is in an unexpanded or delivery configuration, (b) is an
expanded or deployed configuration, or both (a) and (b), according
to some embodiments. In some embodiments, a helical configuration
of the second particular portion 309c of a first elongate member
304 (e.g., a first elongate member 304-1a1 in the first set 309c-1a
of the elongate members 304) is axially or longitudinally offset
from a helical configuration of the second particular portion 309c
of a second elongate member 304 (e.g., a second elongate member
304-2a2 in the second set 309c-2a of the elongate members 304) at
least when the structure 308 (a) is in an unexpanded or delivery
configuration, (b) is in an expanded or deployed configuration, or
both (a) and (b). In some embodiments, a helically configured
second particular portion 309c of a first elongate member 304
(e.g., a first elongate member 304-1a1 in the first set 309c-1a of
the elongate members 304) is axially or longitudinally offset from
a helically configured second particular portion 309c of a second
elongate member 304 (e.g., a second elongate member 304-2a2 in the
second set 309c-2a of the elongate members 304) at least when the
structure 308 (a) is in an unexpanded or delivery configuration,
(b) is in an expanded or deployed configuration, or both (a) and
(b).
[0226] The use of offset (e.g., axial or longitudinal offset)
helically configured second particular portions 309c or offset
(e.g., axial offset) groups of helically configured second
particular portions 309c (forming collective helical
configurations) may be motivated for different reasons. For
example, in some embodiments in which the second particular
portions 309c are located within the elongated portion 316c of the
shaft member 316, axial or longitudinal offset between various ones
of the helical second particular portions 309c may be employed to
produce an arrangement of reduced dimensions as compared to an
arrangement in which the helical second particular portions 309c
are all arranged in a single collective helix configuration. While
a single collective helical configuration of second particular
portions 309c is beneficial and provides improved bending
characteristics according to some embodiments of the present
invention, multiple collective helical configurations, such as the
axially offset collective helical configurations shown in FIGS. 3G
and 3H, may also provide additional benefits, such as space
efficiency, according to some embodiments. Such an offset
arrangement in turn may allow the use of shaft elongated portion
309c with smaller cross-sectional dimensions which may facilitate
percutaneous or intravascular delivery thereof. Further, offset
helical second particular portions 309c may also more evenly
distribute internal stiffness of the shaft member 316 to thereby
allow for more evenly distributed bending characteristics of the
shaft member 316 and improve delivery performance of the shaft
member 316 and positioning of the structure 308 within a bodily
cavity. Further still, offset helical second particular portions
309c may also provide more evenly distributed bending
characteristics to a greater (e.g., longer) portion of the shaft
member 316.
[0227] According to some embodiments, such as those shown in FIGS.
3G and 3H, the second particular portions 309c each extend along a
same rotational direction (e.g., a same clockwise direction or a
same counterclockwise direction depending on viewing direction)
when the structure 308 is at least in an unexpanded or delivery
configuration, according to some embodiments. In this regard, in
some embodiments, the second particular portions 309c of the first
set 309c-1a of the elongate members 304 forming a first collective
helical configuration extend along a same rotational direction
(e.g., a same clockwise direction or a same counterclockwise
direction) at least (a) when the structure 308 is in the unexpanded
or delivery configuration, (b) when the structure 308 is in the
expanded or deployed configuration, or both (a) and (b). Similarly,
according to some embodiments, the second particular portions 309c
of the second set 309c-2a of the elongate members 304 forming a
second collective helical configuration extend along a same
rotational direction (e.g., a same clockwise direction or a same
counterclockwise direction) at least (a) when the structure 308 is
in the unexpanded or delivery configuration, (b) when the structure
308 is in the expanded or deployed configuration, or both (a) and
(b). In some embodiments, the second particular portions 309c of
the first set 309c-1a of the elongate members 304 forming the first
collective helical configuration and the second particular portions
309c of the second set 309c-2a of the elongate members 304 forming
the second collective helical configuration extend along a same
rotational direction (e.g., a same clockwise direction or a same
counterclockwise direction) at least (a) when the structure 308 is
in the unexpanded or delivery configuration, (b) when the structure
308 is in the expanded or deployed configuration, or both (a) and
(b).
[0228] In some embodiments, the second particular portion 309c of a
first elongate member 304 (e.g., the first elongate member 304-1a1
in the first set 309c-1a of the elongate members 304) extends along
a same rotational direction as the second particular portion 309c
of a second elongate member 304 (e.g., the second elongate member
304-2a2 in the second set 309c-2a of the elongate members 304) at
least when the structure 308 is in an unexpanded or delivery
configuration, the same rotational direction being a same clockwise
direction or a same counterclockwise direction. In some
embodiments, the second particular portion 309c of a first elongate
member 304 extends along a different rotational direction than a
rotational direction extended along by the second particular
portion 309c of a second elongate member 304 at least when the
structure 308 is in an unexpanded or delivery configuration.
[0229] Each of various ones of the second particular portions 309c
includes a helical configuration that includes at least 360 degrees
of rotation in some embodiments, at least 540 degrees of rotation
in some embodiments, and at least 720 degrees of rotation in some
embodiments. The amount of rotation of the helical configuration of
a second particular portion 309c of various ones of the elongate
members 304 may be motivated by different reasons. For example, in
FIGS. 3G and 3H, each of the second particular portions 309c of the
elongate members 304 in each of the first set and second sets
309c-1a, 309c-2a include a helical form that undergoes a particular
amount of rotation over a particular length. The helical form
imparts enhanced bending flexibility along the particular length of
the second particular portion 309c. Therefore, according to some
embodiments, the particular length of the second particular portion
309c may be varied based on the amount of rotation or the number of
turns that the helical form undergoes. For example, in some
embodiments, increased lengths of various ones of the second
particular portions 309c having enhanced bending flexibility may be
achieved at least in part by employing helical forms with greater
amounts of rotation or greater numbers of turns. In some
embodiments in which the second particular portions 309c are
located within the elongated portion 316c of the shaft member 316,
a desired length of enhanced flexibility in the shaft member 316 or
an ability of the shaft member 316 to be bent with a particular
bending radius may be achieved at least in part by employing
various elongate members 304 whose second particular portions 309c
have a helical configuration that includes a particular amount of
rotation suitable to provide that particular capability.
[0230] In some embodiments, one or more control elements (e.g.,
356) may be coupled to one or more of the elongate members 304 to
control positioning or orientation of one or more of the elongate
members 304. For example, a control element may be coupled to at
least one elongate member 304 of the plurality of elongate members
to at least in part control, for example, a positioning, tensioning
or a configuration of at least the at least one elongate member 304
or at least one other elongate member 304. Previously cited U.S.
Pat. No. 9,452,016, issued Sep. 27, 2016, includes disclosures
regarding one or more control elements at least in part
controlling, e.g., positioning, tensioning or a configuration of at
least one elongate member, and U.S. Pat. No. 9,452,016, issued Sep.
27, 2016 is hereby incorporated herein by reference in its
entirety.
[0231] According to some embodiments, such as those shown in FIGS.
3G and 3H, a control element 356 is coupled to each of at least a
first particular set of the plurality of elongate members 304 to at
least in part control a configuration of at least a second
particular set of the plurality of elongate members 304. For
example, in some embodiments, the control element 356 may be
configured to transmit force provided by an actuator to facilitate,
at least in part, a desired configuration in one or more of the
elongate members 304. In some embodiments, the control element 356
may be configured to transmit force provided by an actuator to
facilitate a movement of the structure 308 at least in part between
an unexpanded or delivery configuration and an expanded or deployed
configuration. Without limitation, control element 356 may include
one or more control lines or cables, one or more control rods, one
or more Bowden cables, or one or more other force transmission
components. According to some embodiments, such as those shown in
FIGS. 3G and 3H, the control element 356 includes a control line
356b located in a lumen of a control sleeve 356a. It is noted that
control sleeve 356a is partially sectioned to show control line
356b. Control element 356 may be coupled to various ones of the
elongate members 304 at various locations. For example, control
element 356 may be coupled to the first particular portion 309a of
each of at least some of the elongate members 304 according to some
embodiments, although other coupling locations are possible in
other embodiments.
[0232] According to some embodiments, such as the helical
configurations shown in at least FIGS. 3D, 3E, 3G, and 3H, the
plurality of elongate members 304 wrap around at least a portion of
the control element 356 at least (a) when the structure 308 is in
an unexpanded or delivery configuration, (b) when the structure 308
is in an expanded or deployed configuration, or both (a) and (b).
In some embodiments, the second particular portions 309c of some or
all of the plurality of elongate members 304 wrap around at least a
portion of the control element 356 at least (a) when the structure
308 is in an unexpanded or delivery configuration, (b) when the
structure 308 is in an expanded or deployed configuration, or both
(a) and (b). In various embodiments, wrapping at least a portion of
the control element 356 with various particular portions of various
ones of the elongate members 304 may provide a spatially efficient
arrangement since essentially unoccupied space provided by the
wrapping particular portions of the various ones of the elongate
members 304 may be effectively employed. According to some
embodiments, such as those shown in FIGS. 3D, 3E, 3G, and 3H, the
second particular portions 309c of the plurality of elongate
members 304 wrap around the control element 356 along a same
rotational direction at least (a) when the structure 308 is in an
unexpanded or delivery configuration, (b) when the structure 308 is
in an expanded or deployed configuration, or both (a) and (b). The
same rotational direction may be a same clockwise direction or a
same counterclockwise direction. In some embodiments, the second
particular portions 309c of at least some of the plurality of
elongate members 304 may wrap around the control element 356 along
different or opposing rotational directions at least (a) when the
structure 308 is in an unexpanded or delivery configuration, (b)
when the structure 308 is in an expanded or deployed configuration,
or both (a) and (b).
[0233] The characteristics of the helical stacking configurations
of the second particular portions 309c discussed above with respect
to double helical configuration of FIGS. 3G and 3H, including the
collective stacking of multiple elongate members 304, the elongate
member contour following, and elongate member nesting, etc., also
apply to the double helical configuration of FIG. 3E, as well as a
single helical configuration, such as that shown in FIG. 3D, and a
twisted, non-helical configuration, such as that shown in FIG. 3F.
For instance, in a case where the set of elongate members 304y
includes multiple elongate members 304 and the set of elongate
members 304z includes multiple elongate members 304, such multiple
elongate members 304 may form a collective helical or a collective
twisted, non-helical configuration, respectively, and one elongate
member 304 may follow a contour of or be nested with another
elongate member 304 in the respective set, in the manners discussed
above with respect to the double helical configuration of FIGS. 3G
and 3H. In this regard, in some implementations, at least some
double helical configurations (e.g., FIGS. 3E, 3G, and 3H), may
provide improved bending characteristics at potentially increased
cost as compared to at least some single helical configurations
(e.g., FIG. 3D), and, in some implementations, at least some single
helical configurations may provide improved bending characteristics
at potentially increased cost as compared to at least some twisted,
non-helical configurations (e.g., FIG. 3F). However, all of these
configurations (double helical, single helical, and twisted,
non-helical) tend to provide improved bending characteristics as
compared to non-twisted, non-helical configurations. Accordingly,
depending on needs, double helical, single helical, or twisted,
non-helical configurations may be suitable in different
circumstances.
[0234] With regard to twisted, non-helical configurations,
reference is made to various embodiments based at least on FIG. 3F.
In some embodiments, the set 304y of at least some of the elongate
members 304 may represent a plurality of elongate members 304 in a
collective twisted, non-helical configuration or stack. In this
regard, each elongate member 304 includes a second portion 309c,
which is located within the elongated portion of the shaft member
316 as previously discussed. Further in this regard, each second
portion 309c includes a twisted, non-helical configuration
including at least 360 degrees of rotation in some embodiments, at
least 540 degrees of rotation in some embodiments, and at least 720
degrees of rotation in some embodiments. Greater degrees of
rotation may provide a longitudinally longer region of improved
bendability characteristics.
[0235] Unlike helical configurations, the twisted, non-helical
configuration of FIG. 3F intersects its axis of rotation.
Accordingly, in some embodiments, each second portion 309c of each
elongate member 304 in the set 304y of at least some of the
elongate members 304 intersects an axis of rotation of its twisted,
non-helical configuration.
[0236] As discussed above, in some embodiments, the second portions
309c of a set (e.g., 304y) of at least two elongate members 304 are
arranged in a collective twisted, non-helical configuration (a)
when the structure 308 is in the delivery configuration, (b) when
the structure is in the deployed configuration, or both (a) and (b)
since the configuration of the second portions 309c within the
shaft member 316 may be maintained in both the delivery and
deployed configurations of the structure 308. As shown in FIG. 3F,
the second portions 309c of the set (e.g., 304y) of at least two
elongate members 304 may extend along a same rotational direction
in the collective twisted, non-helical configuration (a) when the
structure 308 is in the delivery configuration, (b) when the
structure is in the deployed configuration, or both (a) and (b),
where the same rotational direction may be a same clockwise
direction or a same counterclockwise direction. In some
embodiments, the second portion 309c of each of at least a first
elongate member 304 is nested with the second portion 309c of a
second elongate member 304 (e.g., in the set 304y of elongate
members 304) (a) when the structure is in the delivery
configuration, (b) when the structure is in the deployed
configuration, or both (a) and (b).
[0237] In some embodiments, for each particular elongate member
304, e.g., in the set 304y in FIG. 3F, the first portion 309a of
the particular elongate member 304 and the second portion 309c of
the particular elongate member 304 are provided by a plurality of
portions of the particular elongate member arranged between a
proximal portion (e.g., 307a or 307b) of the particular elongate
member 304 and a distal end 305 of the particular elongate member
304, the plurality of portions of the particular elongate member
304 collectively providing a front surface 318a (one instance shown
in FIG. 3F for a top-most elongate member) of the particular
elongate member 304 and a back surface 318b (one instance shown in
FIG. 3F for a bottom-most elongate member) of the particular
elongate member 304 opposite across a thickness of the particular
elongate member from the front surface 318a of the particular
elongate member 304. At least a particular portion (e.g., first
portion 309a in the non-twisted, non-helical stacked arrangement
in, e.g., FIG. 3A or second portion 309c in the twisted,
non-helical stack in FIG. 3F) of the front surface 318a of a first
elongate member 304 may face at least a particular portion of the
back surface 318b of a second elongate member 304 (e.g., an
elongate member adjacent in the respective stack) when the
structure 308 is in the delivery configuration. In some
embodiments, at least the particular portion of the front surface
318a of the first elongate member 304 follows a contour of at least
the particular portion of the back surface 318b of the second
elongate member 304 at least when the structure 308 is in the
delivery configuration. In some embodiments, at least the
particular portion of the front surface 318a of the first elongate
member 304 follows the contour of at least the particular portion
of the back surface 318b of the second elongate member 304
throughout a rotation of the twisted, non-helical configuration of
the second portion 309c of the second elongate member.
[0238] In some embodiments, at least the second portions 309c of a
first set (e.g., 304y) of at least three of the elongate members
304 may be arranged front surface-toward-back surface in a first
stacked arrangement when the structure 308 is in the delivery
configuration, and at least the second portions 309c of the first
set (e.g., 304y) of at least three elongate members 304 may be
arranged front surface-toward-back surface in a second stacked
arrangement when the structure is in the deployed configuration.
For example, the second portions 309c in FIG. 3F may continue to be
in a stacked arrangement when the structure 308 transitions from
the delivery configuration to the deployed configuration, at least
because the second portions 309c reside within the shaft member 316
and the transition of the structure 308 from the delivery
configuration to the deployed configuration may leave the stacked
arrangement of the second portions 309c relatively unaffected. In
some embodiments, the first portions 309a of the first set (e.g.,
304y) of at least three elongate members are arranged front
surface-toward-back surface in a second stacked arrangement when
the structure is in the delivery configuration (e.g., the first
portions 309a in FIG. 3A are in a non-helical stacked arrangement
that is substantially free from twisting when the structure is in
the delivery configuration). In some embodiments, the first portion
(e.g., 309a) of each elongate member 304 of a plurality of elongate
members 304 is not arranged in a twisted, non-helical configuration
including at least 360 degrees of rotation when the structure 308
is in the delivery configuration.
[0239] In this regard, in contrast to the helical stacking (e.g.,
FIGS. 3D, 3E, 3G, and 3H, according to some embodiments) or the
twisted, non-helical stacking (e.g., FIG. 3F, according to some
embodiments) of the second particular portions 309c, some
embodiments provide a non-twisted, non-helical, such as a linear,
stacked arrangement of the first particular portions 309a. (The
term "non-twisted" in this context is intended to refer to such
portions 309a being substantially free of twist.) With reference to
the examples of FIGS. 3G and 3H for illustration, the first
portions 309a of the first set 309c-1a of the elongate members 304
may be arranged front surface 318a-toward-back surface 318b in a
stacked arrangement (e.g., a stacked arrangement of at least two
elongate members 304 in some embodiments, or a stacked arrangement
of at least three of the elongate members 304 in other embodiments)
at least when the structure 308 is in an unexpanded or a delivery
configuration (e.g., as shown in FIG. 3A or the right side of each
of FIGS. 3G and 3H). In some embodiments, the first portions 309a
of the second set 309c-2a of the elongate members 304 may be
arranged front surface 318a-toward-back surface 318b in a stacked
arrangement (e.g., a stacked arrangement of at least two elongate
members 304 in some embodiments, or a stacked arrangement of at
least three of the elongate members 304 in other embodiments) at
least when the structure 308 is in an unexpanded or a delivery
configuration (e.g., also as shown in FIG. 3A or the right side of
each of FIGS. 3G and 3H). In some embodiments, both the first
portions 309a of the first set 309c-1 and the second set 309c-2a of
the elongate members 304 may be arranged front surface
318a-toward-back surface 318b in a combined stacked arrangement
(e.g., as shown in the right side of each of FIGS. 3G and 3H). That
is, while the second portions 309c of the elongate members 304 may
be arranged in a set of one or more helical or twisted, non-helical
stacked arrangements (e.g., one helical stacked arrangement in some
embodiments of FIG. 3D, two helical stacked arrangements according
to some embodiments of each of FIGS. 3E, 3G, and 3H, and one
twisted, non-helical stacked arrangement in some embodiments of
FIG. 3F, although other numbers of stacked arrangements may be
provided), the first portions 309a may be arranged in a set that is
made up of the same or fewer stacked arrangements than those
comprised by the set of one or more helical stacked arrangements.
For example, the second portions 309c in FIGS. 3E, 3G, and 3H may
be arranged in two collective helical stacked arrangements, and the
first portions 309a may be arranged in a single collective helical
stacked arrangement (e.g., as shown on the right-side of FIGS. 3G
and 3H. In some embodiments, a helical stacked arrangement or a
twisted, non-helical stacked arrangement of the second particular
portions 309c may be considered a first stacked arrangement, and
the non-twisted, non-helical (e.g., linear) stacked arrangement of
the first particular portions 309a may be considered a second
stacked arrangement.
[0240] In some embodiments, at least some of the elongate members
304 providing first particular portions 309a in a stacked
arrangement are the same as at least some of the elongate members
304 providing the second particular portions 309c in a stacked
arrangement. In some embodiments, at least some of the elongate
members 304 providing first particular portions 309a in a stacked
arrangement are other than at least some of the elongate members
providing the second particular portions 309c in a stacked
arrangement. For example, as shown in FIGS. 3G and 3H, the at least
some of the elongate members 304 (e.g., the elongate members 304 of
the set 309c-2a) that provide at least some of the first particular
portions 309a in a stacked arrangement are other than the elongate
members that provide the second particular portions 309c in a
stacked arrangement (e.g., the helical stacked arrangement provided
the elongate members 304 of the set 309c-1a).
[0241] FIGS. 3G and 3H include a collar 316b1 at a transition
region between the illustrated double helical configuration of the
second portions 309c and the non-twisted, non-helical configuration
of the first portions 309a (with the twisted portion 345 between
the portions 309c and 309a). The same or a similar collar may be
used for single helical configurations (e.g., FIG. 3D) or twisted,
non-helical configurations (e.g., FIG. 3F) of the second portions
309c.
[0242] For further detail, FIGS. 3I and 3J illustrate examples of a
transition region between double helical configurations of the
second portions 309c and non-twisted, non-helical configurations of
the first portions 309a, according to some embodiments. In
particular, FIGS. 3I and 3J illustrate examples of a transition
region between double helical configurations of the second portions
309c and an elongate member portion just proximally before twisted
region 345 occurs, according to some embodiments. In this regard,
FIG. 3I illustrates a transition from a rotationally offset double
helical configuration to a non-twisted, non-helical configuration
in a region 344 just proximally before twisted region 345,
according to some embodiments. A rotationally offset double helical
configuration is differentiated from the axially or longitudinally
offset configurations illustrated in, e.g., FIGS. 3G and 3H. On the
other hand, FIG. 3J illustrates a transition from an axially or
longitudinally offset double helical configuration to a
non-twisted, non-helical configuration in a region 344 just
proximally before twisted region 345, according to some
embodiments. In this regard, the axially or longitudinally offset
double helical configuration illustrated in FIG. 3J corresponds to
the axially or longitudinally offset double helical configuration
illustrated in, e.g., FIGS. 3G and 3H. The non-twisted, non-helical
region 344 just proximally before twisted region 345 illustrated in
FIGS. 3G and 3H has been exaggerated to enhance the illustration of
the unwinding of the respective double helical configurations.
[0243] FIGS. 3I and 3J remove the collar 316b1 and the shaft member
316 shown in at least FIGS. 3G and 3H for purposes of clarity. In
addition, FIGS. 3I and 3J illustrate only a single elongate member
304w (of elongate members 304) for one helix and a single elongate
member 304x (of elongate members 304) for the other helix of the
respective double helical configuration for purposes of clarity.
Other numbers of elongate members 304 may be provided according to
various embodiments. Also, as with FIGS. 3D, 3E, and 3F, only a
single control element 356 is called out, and different numbers of
control elements 356 besides those illustrated may be provided
according to various embodiments.
[0244] For additional detail regarding the winding of the axially
offset double helical configuration (e.g., FIG. 3J) and the
circumferentially offset double helical configuration (e.g., FIG.
3I), reference will now be made to FIGS. 3K and 3L.
[0245] FIG. 3K shows a plurality of elongate members 304 in a state
prior to winding into a circumferentially or rotationally offset
double helical configuration (e.g., FIG. 3I), according to some
embodiments. Each of the elongate members 304 includes a distal end
305, a proximal end (e.g., 307) and a plurality of particular
portions arranged between the distal end 305 and proximal end
(e.g., 307). The plurality of particular portions include portions
309a, 309b, 309c, and 345 that are the same or similar to
particular portions described earlier and having the same
respective part (reference) number. For clarity, the elongate
members 304 in FIG. 3K are shown in a "flattened" or an
"undistorted" state, according to some embodiments. For example,
particular portions 345 are shown in an untwisted state as opposed
to the twisted state shown, e.g., in FIGS. 3A and 3B. By way of
another example, particular portions 309c are shown without a
helical configuration as opposed to the presence of a helical
configuration in such portions 309c as described above. It is
understood that various particular portions of elongate members 304
in FIG. 3K may, in some embodiments, include, for example, at a
later time, or upon subsequent processing, various helical
configurations. For example, in FIG. 3K, the various elongate
members 304 are shown with a "flattened" or "planar" form that may
exist, according to some embodiments, prior to subsequent
processing or manipulation that imparts some distortions to the
`flattened or "planar" forms (e.g., distorted forms such as shown
at least in FIGS. 3A and 3I).
[0246] According to some embodiments, the particular portion 309c
of various ones of the elongate members 304 is arranged with a
skewed orientation (e.g., a dog-legged) orientation with respect to
another particular portion of the respective elongate member 304.
The skewed or dog-legged configuration of particular portion 309c
in the flattened or undistorted state shown, e.g., in FIG. 3K, may
be motivated for different reasons. For example, when the
particular portion 309c is subsequently manipulated to have a
helical configuration (e.g., as shown in FIG. 3I), a change in
angle at the beginning and end of the helical region may be
required to transition into and out of (respectively) the helical
shape to create a small form factor (e.g., a small overall shape
capable of fitting within the confines of the elongated portion
316c of the shaft member 316). Without the change in angle provided
by the skewed or dog-legged configuration of the particular portion
309c, particular portion 309c could bend out of plane when bent to
comprise a helical configuration and thereby create a bulge that
could provide a larger than desired shape or size. In FIG. 3K, the
particular portions 309c of a first group 304-1 of the elongate
members 304 are skewed with a first particular orientation (e.g., a
positive skewed orientation), while the particular portions 309c of
a second group 304-2 of the elongate members 304 are skewed with a
second particular orientation (e.g., a negative skewed orientation)
different than the first particular orientation according to some
embodiments. In some embodiments, the change in orientation between
the particular portions 309c in the first group 304-1 and the
particular portions 309c in the second group 304-2 may be employed
to cause, when the particular portions 309c are coiled into a
helix, the start 311 of the helix of each particular portion 309c
in the first group 304-1 to be rotationally positioned at a
different location than the start 311 of the helix of each
particular portion 309c in the second group 304-2. For example, in
some embodiments, a viewing perspective along the axis of the
formed helices would indicate that the start 311 of the helix of
each particular portion 309c in the first group 304-1 would start,
for example, at the 12 o'clock position while the start 311 of the
helix of each particular portion 309c in the second group 304-2
would start at a rotationally offset position, for example, at the
6 o'clock position. According to some embodiments, such as those
shown in FIG. 3I, employing different rotational starts as
described above may be employed to achieve an axial offset between
the helical portion 309c of elongate member 304w, for example, and
the helical portion 309c of the second elongate member 304w, for
example, to form a multi-helix structure (e.g., a multi-helix
structure including a form similar to that of a double helix
structure employed by DNA (Deoxyribonucleic acid)). It is noted
that start 311 of each of the "flattened" particular portions 309c
in FIG. 3K is depicted by a broken line positioned to represent
that each of their respective helices start at the same
substantially same axial position despite some of them starting at
different rotational positions, according to some embodiments.
[0247] FIG. 3L shows a plurality of elongate members 304 in a state
prior to winding into an axially or longitudinally offset double
helical configuration (e.g., FIG. 3J), according to some
embodiments. The plurality of elongate members 304 include similar
features and are arranged in similar groupings to those shown in
FIG. 3K, and the same or similar part numbers employed in FIG. 3K
are employed in FIG. 3L for convenience of discussion. Accordingly,
each of the elongate members 304 includes a distal end 305, a
proximal end (e.g., 307) and a plurality of particular portions
arranged between the distal end 305 and proximal end (e.g., 307).
The plurality of particular portions include portions 309a, 309b,
309c, and 345 that that are the same or similar to particular
portions described earlier and having the same respective part
(reference) number. In a manner similar to, or the same as in, FIG.
3K, the elongate members 304 in FIG. 3L are shown in a "flattened"
or an "undistorted" state, according to some embodiments. For
example, particular portions 345 are shown in an untwisted state as
opposed to a twisted state shown in FIG. 3A. By way of another
example, particular portions 309c are shown without a helical
configuration as opposed to the presence of a helical configuration
as shown, for example, in FIGS. 3G, 3H, and 3J. It is understood,
that various particular portions of elongate members 304 in FIG. 3L
may, in some embodiments, include, for example, at a later time, or
upon subsequent processing, various twisted or helical
configurations. For example, in FIG. 3L, the various elongate
members 304 are shown with a "flattened" or "planar" form that may
exist, according to some embodiments, prior to subsequent
processing or manipulation that imparts some distortions to the
`flattened` or "planar" forms (e.g., distorted forms such as shown
at least in FIGS. 3A, 3G, 3H, and 3J).
[0248] According to some embodiments, the particular portion 309c
of various ones of the elongate members 304 is arranged with a
skewed orientation (e.g., a dog-legged) orientation with respect to
other particular portion of the respective elongate member 304. The
skewed or dog-legged configuration of particular portion 309c in
the flattened or undistorted state shown, e.g., in FIG. 3L, may be
motivated for different reasons including the reasons expressed
above with respect to FIG. 3K. A comparison of the embodiments of
FIGS. 3K and 3L indicates that unlike FIG. 3K in which the
particular portions 309c of the first group 304-1 of the elongate
members 304 are skewed with a first particular orientation that is
different than the orientation of the particular portions 309c of
the second group 304-2 of the elongate members 304, in FIG. 3L,
both the particular portions 309c of the first group 304-1 of the
elongate members 304 and the second group 304-2 of elongate members
304 are skewed with the same orientation (e.g., a positive
orientation as discussed in above with respect to FIG. 3K).
Additionally in FIG. 3L, an axial or longitudinal offset between
particular portions 309c in the first group 304-1 and the
particular portions 309c in the second group 304-2 may be employed
according to some embodiments to cause, when the particular
portions 309c are coiled into a helix, the start 311a of the helix
of each particular portion 309c in the first group 304-1 to be
axially or longitudinally positioned at a different location than
the start 311b of the helix of each particular portion 309c in the
second group 304-2.
[0249] In some embodiments, differences between the axial starts
311a, 311b of the particular portions 309c in the first group 304-1
and the particular portions 309c in the second group 304-2 may be
employed to cause, when the particular portions 309c are coiled
into a helix, the start of the helix of each particular portion
309c in the first group 304-1 to be axially or longitudinally
positioned at a different location than the start of the helix of
each particular portion 309c in the second group 304-2. According
to some embodiments, such as those shown in FIGS. 3G, 3H, and 3J,
employing different axial or longitudinal starts as described above
may be employed to achieve an axial or longitudinal offset between
the helical portions 309c in the first set 309c-1 and the helical
portions 309c in the second set 309c-2, to form a multi-helix
structure (e.g., a multi-helix structure including a form similar
to that of a double helix structure employed by DNA
(Deoxyribonucleic acid)). It is noted that start 311 of each of the
"flattened" particular portions 309c in the second group 304-2 in
FIG. 3L is depicted by a broken line positioned to represent that
each of their respective helices start at different axial or
longitudinal positions, according to some embodiments.
[0250] In some embodiments, for each elongate member 304 of at
least some of the elongate members of the plurality of elongate
members 304, a dimension or size of at least one of the particular
portions of the elongate member 304 is different than a
corresponding dimension or size of at least one other particular
portion of the elongate member 304. For example, in FIGS. 3K and
3L, the width 323-a of the second particular portion 309c of at
least one of the elongate members 304 is smaller than the
corresponding width of another of the particular portions (for
example, the width 323-b of particular portion 309d (e.g., proximal
portion 307a or 307b) of the at least one of the elongate members
304). According to some embodiments, varying a size or dimension
such as the width 323 among various particular portions of at least
one of the elongate members 304 may be motivated by different
reasons. For example, at least one elongate member 304 may employ a
second particular portion 309c that has a reduced width as compared
the corresponding width of at least some of the other particular
portions of the at least one elongate member 304 to allow the
second particular portion 309c to more readily assume the helical
configuration or to allow the second particular portion to assume a
helical configuration of a desired reduced size or of particular
size required by some particular spatial constraints (e.g., fitting
within the confines of a lumen in shaft member 316). In some
embodiments, both the second particular portions 309c and
particular portions 309d are subject to the same spatial
constraints (for example, both portions be required to extend
through one or more lumens in shaft member 316). In various
embodiments, the particular second portions 309c are helically
configured to provide a particular benefit (e.g., enhanced
flexibility of the shaft member 316) while the particular portions
309d are arranged in some other configuration which may not provide
this particular benefit or may provide some other benefit. For
example, the particular portions 309d may extend through a large or
major portion of the shaft member 316 that does not require
enhanced flexibility and thus these portions may be arranged in a
non-helical configuration and may adopt larger widths. In some
embodiments, for example, when at least the particular portions
309d are provided by flexible circuit structures or may extend
sufficiently to provide a large or major portion of conductors 317,
larger widths 323 for the portions 309d may be desired to provide
additional space for electrical traces or conductors of larger
width, the larger widths of the traces or conductors advantageously
associated with reduced electrical resistance losses over large
spans.
[0251] In this regard, with respect to FIGS. 3K and 3L, for each
particular elongate member 304 of the plurality of elongate members
304: the second portion 309c of the particular elongate member 304
is between a proximal portion (e.g., 309d or 307a or 307b) of the
particular elongate member 304 and the first portion e.g., 309a of
the particular elongate member along a length of the particular
elongate member 304, and the first portion 309a of the particular
elongate member 304 is between the second portion 309c of the
particular elongate member 304 and a distal end 305 of the
particular elongate member 304 along the length of the particular
elongate member 304, according to some embodiments. In some
embodiments, a first width 323-a of the particular elongate member
304 in the second portion 309c is at least 10% less than a
corresponding second width 323-b of the particular elongate member
304 in the proximal portion (e.g., 309d or 307a or 307b) of the
particular elongate member 304. In some embodiments, the first
width 323-a of the particular elongate member 304 in the second
portion 309c is between 20% and 60%, inclusive, less than the
corresponding second width 323-b of the particular elongate member
304 in the proximal portion of the particular elongate member 304.
In some embodiments, the first width 323-a of each elongate member
304 is 3 mm and the second width 323-b of each elongate member 304
is 4.7 mm.
[0252] In some embodiments, wherein, for each particular elongate
member 304 of the plurality of elongate members 304: the first
portion 309a of the particular elongate member 304 and the second
portion 309c of the particular elongate member 304 are provided by
a plurality of portions of the particular elongate member 304
arranged between a proximal portion (e.g., 309d or 307a or 307b) of
the particular elongate member 304 and a distal end 305 of the
particular elongate member 304. The plurality of portions of the
particular elongate member 304 may collectively provide a front
surface 318a of the particular elongate member 304 and a back
surface 318b of the particular elongate member 304 opposite across
a thickness of the particular elongate member 304 from the front
surface 318a of the particular elongate member 304, and the
thickness of the particular elongate member 304 may be
perpendicular to a longitudinal axis of the particular elongate
member 304. In some embodiments, wherein, for each particular
elongate member 304 of the plurality of elongate members 304: a
first width 323-a of the particular elongate member 304 in the
second portion 309c of the particular elongate member 304 is at
least 10% less, or in some embodiments is between 20% and 60%,
inclusive, less than a second width 323-b of the particular
elongate member 304 in the proximal portion (e.g., 309d or 307a or
307b) of the particular elongate member 304, and each of the first
width 323-a and the second width 323-b is perpendicular to the
thickness and the longitudinal axis of the particular elongate
member 304. In some embodiments, the first widths 323-a of the
elongate members 304 are equal or within 5% of a same width. In
some embodiments, for each particular elongate member of the
plurality of elongate members: the proximal portion (e.g., 309d or
307a or 307b) of the particular elongate member 304 is adjacent the
second portion 309c of the particular elongate member 304 along the
longitudinal axis of the particular elongate member 304, and, in a
state where the longitudinal axis of the particular elongate member
304 resides within a same plane (e.g., as shown in the flattened
states of FIGS. 3K and 3L), the longitudinal axis of the particular
elongate member 304 bends by a bending angle (one shown in each of
FIGS. 3K and 3L with reference numeral 380 pointing to the angle
between the two intersecting dotted lines) between the proximal
portion (e.g., 309d or 307a or 307b) of the particular elongate
member 304 and the second portion 309c of the particular elongate
member 304. An absolute value of the bending angle is at least 5
degrees, in some embodiments, and between 10 and 20 degrees,
inclusive, in some embodiments. In some embodiments, the bending
angle for each elongate member 304 in a first subset (e.g., 304-2)
of at least two elongate members 304 of the plurality of elongate
members 304 is positive, and the bending angle for each elongate
member 304 in a second subset (e.g., 304-1) of at least two
elongate members 304 of the plurality of elongate members 304 is
negative, the elongate members in the first subset other than the
elongate members in the second subset.
[0253] While some of the embodiments disclosed above are described
with examples of cardiac ablation, the same or similar embodiments
may be used for ablating other bodily organs or any lumen or cavity
into which the devices of the present invention may be
introduced.
[0254] Subsets or combinations of various embodiments described
above provide further embodiments.
[0255] These and other changes may be made to various embodiments
in light of the above-detailed description. In general, in the
following claims, the terms used should not be construed to limit
the invention to the specific embodiments disclosed in the
specification and the claims, but should be construed to include
other electrode-based device systems including all medical
treatment device systems and all medical diagnostic device systems
in accordance with the claims. Further, it should be noted that,
although several of the above-discussed embodiments are described
within the context of an intra-cardiac medical device system, other
embodiments apply to other medical and non-medical device systems.
Accordingly, the invention is not limited by this disclosure, but
instead its scope is to be determined entirely by the claims.
* * * * *